128 Legal Affairs jobs in the United Kingdom
Regulatory Affairs Assistant
Posted 9 days ago
Job Viewed
Job Description
Regulatory Affairs Assistant - Devon - up to 25,000 + Bonus + Benefits - REF 1935
I am currently recruiting for a Regulatory Affairs Assistant to work for a leading engineering organisation based in Devon. Salary up to 25,000 + Bonus + Benefits.
The company are leaders within their field of expertise and are seen as the go to organisation within their specialist product area, not only in the UK, but on an international basis. They have multiple offices throughout the UK, as well as being strategically positioned throughout the world. They have gone from strength to strength over recent years and via organic growth as well as a range of acquisitions they have strengthened their client offering ensuring they stay at the forefront of the market.
To support the growth of the business they now have the need to appoint a Regulatory Affairs Assistant on a permanent basis.
In this role as a Regulatory Affairs Assistant, you will primarily be responsible for the regulatory submissions. This will involve gaining approval for the organisations products within their applicable markets for a range of countries. You will also get involved in post market surveillance, vigilance reporting and field safety correction actions under the supervision or experienced Regulatory professionals.
Essential Requirements:
- Degree in a Science related field (ideally Biology, Biomedical or Chemistry)
Desirable Requirements:
- Previous experience as a Regulatory Affairs Assistant or similar
This is an entry level role, so full training and support will be provided.
This is a fantastic opportunity for a Regulatory Affairs Assistant to work for a leader within their field. The company has very ambitious, but realistic growth plans and this role is part of the business's succession planning, so stability and progression are both on offer with this opportunity.
This is an immediate requirement so if you have the required skills and experience then please get in touch ASAP with an up-to-date copy of your CV. Either apply direct or contact Adam on (phone number removed).
Regulatory Affairs Manager
Posted 13 days ago
Job Viewed
Job Description
Are you an experienced Regulatory Affairs Manager looking to make a impact in the chemical manufacturing industry? We are seeking a proactive and detail-oriented professional to lead the regulatory strategy and ensure full compliance across site operations.
As a Regulatory Affairs Manager , you will play a critical role in navigating complex regulatory environments, working cross-functionally with R&D, production, quality, and commercial teams to support product compliance and market access. Your expertise will directly influence the ability to innovate safely and responsibly.
Key Responsibilities of Regulatory Affairs Manager :
- Serve as the primary Regulatory Affairs Manager for all chemical regulatory matters, including REACH, TSCA, SEPA and other global compliance frameworks.
- Prepare, submit, and maintain product registration dossiers and regulatory filings.
- To complete the REACH registration of the full product range within the time limits set by ECHA.
- Work closely with the SHE Manager and operations to ensure that the manufacturing process, human health and environmental exposure meet the scope of the CSR for each registered product.
- Maintain material safety data sheet for all products which conform to the legislative requirements of both the U.K. and the countries into which the products are sold.
- Collaborate closely with internal stakeholders to integrate regulatory requirements into product development and manufacturing processes.
- Represent the company with regulatory agencies and industry associations.
- Interpret regulatory legislation as applied to chemical entities so that the company can achieve its registration requirements in full, on time and at the most efficient cost; Monitoring and interpreting regulatory changes, advising the business on potential impacts
Qualifications required from Regulatory Affairs Manager :
- Bachelor's degree or higher in Chemistry, Chemical Engineering, Regulatory Affairs, or related field.
- Minimum 3-5 years' experience in regulatory affairs within chemical manufacturing.
- Working knowledge of international chemical regulations and compliance systems.
- Strong communication and interpersonal skills-ability to work well with people across all levels of the organisation.
What We Value:
We're looking for someone who not only excels in as a Regulatory Affairs Manager but also thrives in a team-oriented environment and helps foster a positive, values-driven workplace.
This is a chance to join a company that values innovation, and strong relationships. If you're ready to bring your regulatory expertise to a team where culture matters, we'd love to hear from you.
Apply today to become our next Regulatory Affairs Manager and help shape the future of safe, sustainable chemical manufacturing.
Regulatory Affairs Specialist
Posted 13 days ago
Job Viewed
Job Description
Regulatory Specialist for a leading multinational coatings company based in the North Lancashire area.
Company: Leading coatings manufacturer, which owns some of the largest and most recognisable brands in the UK and the rest of the world. Profits from the organisation go towards education funds and other worthwhile causes.
Hours of work: Flexible working hours - 37.5 hours per week, starting between 7am and 10am and finishing between 4pm and 6pm.
Why join?
- Excellent salary and very generous pension plan.
- Stable and growing business.
- Internal investment into people, facilities and innovation.
- 28 days + 8 Bank holidays.
- Health and wellbeing benefits.
- Working for a foundation which funds education projects around the world.
- Leading sustainability strategy.
- Longer term - flexibility with home and office working.
- Fantastic teams with lots of knowledge and experience.
Location: North Lancashire.
Duration: Permanent
Salary: Up to 60k (depending upon your experience)
You will be involved in:
- Providing Regulatory support and guidance (for UK REACH and BPR - Biocidal product regulations) to R&D and planning departments.
- Ensuring that existing and new products adhere to regulatory standards (REACH, CLP and BPR).
- Authoring MSDS, product labels and updating product databases (UFI registrations).
- Representing the company and liaising with trade bodies/technical committees/government officials in matters relating to regulatory affairs.
- Keeping abreast of new regulations and laws and how this will impact products and advising on alternative options where possible.
What do you need to be considered?
You will need:
- Strong background (5+ years) in chemical regulatory affairs - REACH, BPR, CLP. (EU REACH would be a distinct advantage).
- Experience of authoring MSDS and products labels.
- Knowledge of regulatory affairs and EH&S in one of the following areas: chemicals, coatings, inks, paints, cosmetics.
- Science based qualification ideally within chemistry or closely related subject.
- Excellent database, communication (written and verbal) and project management skills.
What to do next.
Interested?
If you have a passion for Regulatory and Compliance and want to work for a company which has ambitious growth plans; has strong ethical and sustainability values and offers an amazing salary and benefits, then this is the role for you!
Apply now to avoid disappointment as the company is looking to review CVs immediately.
Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
Regulatory Specialist for a leading multinational coatings company based in the North Lancashire area.
Company: Leading coatings manufacturer, which owns some of the largest and most recognisable brands in the UK and the rest of the world. Profits from the organisation go towards education funds and other worthwhile causes.
Hours of work: Flexible working hours - 37.5 hours per week, starting between 7am and 10am and finishing between 4pm and 6pm.
Why join?
- Excellent salary and very generous pension plan.
- Stable and growing business.
- Internal investment into people, facilities and innovation.
- 28 days + 8 Bank holidays.
- Health and wellbeing benefits.
- Working for a foundation which funds education projects around the world.
- Leading sustainability strategy.
- Longer term - flexibility with home and office working.
- Fantastic teams with lots of knowledge and experience.
Location: North Lancashire.
Duration: Permanent
Salary: Up to 60k (depending upon your experience)
You will be involved in:
- Providing Regulatory support and guidance (for UK REACH and BPR - Biocidal product regulations) to R&D and planning departments.
- Ensuring that existing and new products adhere to regulatory standards (REACH, CLP and BPR).
- Authoring MSDS, product labels and updating product databases (UFI registrations).
- Representing the company and liaising with trade bodies/technical committees/government officials in matters relating to regulatory affairs.
- Keeping abreast of new regulations and laws and how this will impact products and advising on alternative options where possible.
What do you need to be considered?
You will need:
- Strong background (5+ years) in chemical regulatory affairs - REACH, BPR, CLP. (EU REACH would be a distinct advantage).
- Experience of authoring MSDS and products labels.
- Knowledge of regulatory affairs and EH&S in one of the following areas: chemicals, coatings, inks, paints, cosmetics.
- Science based qualification ideally within chemistry or closely related subject.
- Excellent database, communication (written and verbal) and project management skills.
What to do next.
Interested?
If you have a passion for Regulatory and Compliance and want to work for a company which has ambitious growth plans; has strong ethical and sustainability values and offers an amazing salary and benefits, then this is the role for you!
Apply now to avoid disappointment as the company is looking to review CVs immediately.
Regulatory Affairs Assistant
Posted today
Job Viewed
Job Description
Regulatory Affairs Assistant - Devon - up to 25,000 + Bonus + Benefits - REF 1935
I am currently recruiting for a Regulatory Affairs Assistant to work for a leading engineering organisation based in Devon. Salary up to 25,000 + Bonus + Benefits.
The company are leaders within their field of expertise and are seen as the go to organisation within their specialist product area, not only in the UK, but on an international basis. They have multiple offices throughout the UK, as well as being strategically positioned throughout the world. They have gone from strength to strength over recent years and via organic growth as well as a range of acquisitions they have strengthened their client offering ensuring they stay at the forefront of the market.
To support the growth of the business they now have the need to appoint a Regulatory Affairs Assistant on a permanent basis.
In this role as a Regulatory Affairs Assistant, you will primarily be responsible for the regulatory submissions. This will involve gaining approval for the organisations products within their applicable markets for a range of countries. You will also get involved in post market surveillance, vigilance reporting and field safety correction actions under the supervision or experienced Regulatory professionals.
Essential Requirements:
- Degree in a Science related field (ideally Biology, Biomedical or Chemistry)
Desirable Requirements:
- Previous experience as a Regulatory Affairs Assistant or similar
This is an entry level role, so full training and support will be provided.
This is a fantastic opportunity for a Regulatory Affairs Assistant to work for a leader within their field. The company has very ambitious, but realistic growth plans and this role is part of the business's succession planning, so stability and progression are both on offer with this opportunity.
This is an immediate requirement so if you have the required skills and experience then please get in touch ASAP with an up-to-date copy of your CV. Either apply direct or contact Adam on (phone number removed).
Regulatory Affairs Manager
Posted today
Job Viewed
Job Description
Are you an experienced Regulatory Affairs Manager looking to make a impact in the chemical manufacturing industry? We are seeking a proactive and detail-oriented professional to lead the regulatory strategy and ensure full compliance across site operations.
As a Regulatory Affairs Manager , you will play a critical role in navigating complex regulatory environments, working cross-functionally with R&D, production, quality, and commercial teams to support product compliance and market access. Your expertise will directly influence the ability to innovate safely and responsibly.
Key Responsibilities of Regulatory Affairs Manager :
- Serve as the primary Regulatory Affairs Manager for all chemical regulatory matters, including REACH, TSCA, SEPA and other global compliance frameworks.
- Prepare, submit, and maintain product registration dossiers and regulatory filings.
- To complete the REACH registration of the full product range within the time limits set by ECHA.
- Work closely with the SHE Manager and operations to ensure that the manufacturing process, human health and environmental exposure meet the scope of the CSR for each registered product.
- Maintain material safety data sheet for all products which conform to the legislative requirements of both the U.K. and the countries into which the products are sold.
- Collaborate closely with internal stakeholders to integrate regulatory requirements into product development and manufacturing processes.
- Represent the company with regulatory agencies and industry associations.
- Interpret regulatory legislation as applied to chemical entities so that the company can achieve its registration requirements in full, on time and at the most efficient cost; Monitoring and interpreting regulatory changes, advising the business on potential impacts
Qualifications required from Regulatory Affairs Manager :
- Bachelor's degree or higher in Chemistry, Chemical Engineering, Regulatory Affairs, or related field.
- Minimum 3-5 years' experience in regulatory affairs within chemical manufacturing.
- Working knowledge of international chemical regulations and compliance systems.
- Strong communication and interpersonal skills-ability to work well with people across all levels of the organisation.
What We Value:
We're looking for someone who not only excels in as a Regulatory Affairs Manager but also thrives in a team-oriented environment and helps foster a positive, values-driven workplace.
This is a chance to join a company that values innovation, and strong relationships. If you're ready to bring your regulatory expertise to a team where culture matters, we'd love to hear from you.
Apply today to become our next Regulatory Affairs Manager and help shape the future of safe, sustainable chemical manufacturing.
Regulatory Affairs Manager
Posted 4 days ago
Job Viewed
Job Description
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Regulatory Affairs Manager**
Swindon, UK/Full time
**Work Schedule**
Standard (Mon-Fri)
**Job Description**
**Responsibilities:**
Join Thermo Fisher Scientific Inc. as a Manager, Regulatory Affairs, and play a pivotal role in moulding our regulatory strategies!
+ Perform regulatory surveillance
+ Assess regulatory feasibility of any new request (primary focal point) and address local impact.
+ Establish centre of expertise to be shared within Thermo Fisher network.
+ Externally, participate to working groups within professional bodies.
+ Supervise the maintenance of all official authorisations (MIA human and veterinary & MIA IMP - MS - ISO - GMP certificate) and establishment master documentations (SMF - DMF - device technical file) collaborating with appropriate regulatory agencies.
+ Ensure inspections & key audits readiness and/or participate.
+ Responsible for archiving official documents.
+ Supervise the maintenance of regulatory data bases (Client product registration information, components).
+ Ensure integration of registration information into Production and Quality master documents (process and QC specifications).
+ Participate to the Change Control process by defining regulatory requirements.
+ Acknowledge regulatory quotations and follow-up on invoices for reporting of financial indicators.
+ Identify areas of regulatory business opportunities (PDS and others).
+ Provide regulatory guidance (strategy definition, requirements assessment).
+ Coordinate the authoring of CMC/Quality documentations (gap analysis, IND-IMPD, NDA/BLA-MAA, registration questionnaires, pharmaceutical declarations) and review.
+ Supervise Client registration life-cycle activities (renewals, MoH questions).
**Requirements:**
To be successful in this role, you must possess experience in regulatory affairs, particularly within the legal framework. You should have:
+ B.Sc. or equivalent experience in Pharmacy, Chemistry, or Microbiology, or related science
+ A minimum of **7** years hands-on theoretical and practical regulatory affairs (including filling activities) as well as site regulatory compliance activities.
+ UK, European, US & International main pharmaceutical regulations (including GMPs). Knowledge of the workings of UK Ministry of Health.
+ Deep knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements
+ Dynamic, self-motivated, pro-active approach to taking on challenging assignments.
+ Strong communication and collaboration skills
+ Ability to work with critical timelines.
+ Outstanding communication skills, both written and oral, and the self-confidence to use these skills to convince others to buy-into proposals and plans.
We offer a range of flexible benefits including Pension and Healthcare in addition to competitive salaries.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Regulatory Affairs Manager
Posted 4 days ago
Job Viewed
Job Description
**Abbott Diabetes Care**
**Witney, Oxfordshire**
**Competitive Salary + Excellent Benefits**
Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems and test strips for use in both home and hospital settings. Our product portfolio includes Freestyle Libre, a recently launched system that is revolutionising how people with diabetes around the world monitor their glucose levels. We are passionate about doing work that improves the quality of people's lives.
We currently have an opportunity for a Regulatory Affairs Manager to join our team, based in Oxfordshire, supporting the significant manufacturing capacity expansion underway at the Witney site plus other Operational and R&D projects.
**Primary Job Function**
You will set the EU Regulatory Strategy that is well-defined and effective. The strategy sets out innovative solutions to Regulatory Approval so that plans can be set out.
You will oversee the Project Management of regulatory projects, integrating with the US and OUS Regulatory organisation, the R&D organisation and other key functional groups.
**Core Job Responsibilities**
+ Ensures maintenance of strong communication and working relationships with the Alameda RA group and other RA teams globally.
+ Ensures maintenance of strong communication and working relationships with the Clinical Affairs organisation, R&D Development groups and US Project Management.
+ Supports the interface and guidance of any external auditors such as FDA and ISO assessors reviewing Technical Files.
+ Provides leadership on Notified Body strategy and regional/global planning of product registration.
+ Responsible for defining the regulatory strategy for product approvals in EU and region.
+ Each new development project (product) requires a regulatory strategy to be created and maintained.
+ Responsible for supporting RA compliance with site EHS policy and procedures.
+ Responsible for maintaining the effectiveness of the Quality System at the site in accordance with Abbott Corporate requirements and applicable regulations.
+ Excellent communication / negotiating skills for discussions with Notified Bodies and Competent Authorities etc.
**Position Accountability / Scope**
+ Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.
+ This position must ensure that the products are registered in the countries as appropriate and ensure compliance to QS Regulations, ISO regulations, etc.
+ Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.
**Minimum** **Education**
+ Minimum of a Bachelor's degree or equivalent preferably in a Scientific discipline e.g. Chemistry, life Sciences, Biology.
**Minimum** **Experience/Training Required**
+ Minimum of a bachelor's degree is required to ensure that the jobholder has sufficient technical knowledge to effectively and confidently be the Regulatory Affairs Project Mgr in the EMEA region.
+ Knowledge of regulatory requirements for ISO 13485, EMC, MDD (93/42/EEC), IVDD (98/79/EC), MDR 2017/745 & IVDR 2017/756, and FDA Quality Systems Regulations is essential.
+ Experience within a medical or healthcare manufacturing industry in a regulatory role. The position requires an understanding of the needs of the customer and knowledge of regulations and standards affecting IVDs and MDDs, the regulatory bodies and country regulations that govern ADC products to enable the jobholder to interpret and apply regulations and standards to products and processes.
+ You need to have excellent written and oral communication skills necessary to be able to produce succinct reports and documentation and to effectively communicate with other departments, managers and external regulatory organizations.
+ You need to have the depth of Regulatory knowledge to be able to define a Regulatory Strategy that is well defined and effective. Additionally, the depth of experience is required to ensure that innovative solutions to Regulatory Approval paths can be set out.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
Regulatory Affairs Specialist
Posted 4 days ago
Job Viewed
Job Description
Are you a detail-oriented professional with a strong background in regulatory affairs, and pharmacovigilance? Are you looking to make a real impact in a dynamic, fast-paced pharmaceutical environment?
We're seeking a Regulatory Affairs Associate to support our Regulatory Compliance Manager (RCM) in ensuring that our operations stay at the forefront of regulatory excellence and patient safety while also helping us drive forward best practices in compliance, product information, and pharmacovigilance.
This is a full-time role of 37.5 hours, working Monday to Friday, 9am - 5pm. This is a hybrid role, our head office based in Huthwaite, Nottinghamshire.
**What does the role involve?**
**You will:**
+ **Lead local pharmacovigilance (PV)** activities, ensuring systems, reporting, and processes meet MHRA and GVP standards
+ **Support regulatory submissions** (e.g. licence applications, product updates) and keep product information up to date
+ **Review promotional and non-promotional materials** to ensure they comply with ABPI/IPHA codes
+ **Work closely with Marketing and internal teams** to provide clear, compliant advice and guidance
+ **Deliver training** on ABPI codes and PV requirements, and monitor compliance performance
**About You, you will:**
+ A degree in a life science discipline (e.g., Pharmacy, Pharmacology, Chemistry, Biology, Nursing)
+ Experience reviewing promotional materials under the ABPI Code
+ Knowledge of GVP, MDR, Human Medicines Regulation, and medical device vigilance
+ Excellent written and verbal communication skills
+ A proactive, adaptable mindset with the ability to prioritise in a fast-changing environment
+ Ideally have experience in regulatory submissions and medical device complaint handling (training can be provided)
**What can we offer you?**
Here at Fresenius Medical Care, we value the contribution of our people and ensure that we offer industry-leading rewards and progression.
We offer a competitive salary alongside a wealth of other fantastic benefits listed below:
+ Company Pension Scheme
+ Life Assurance
+ 33 Days Holiday (inclusive of 8 days bank holiday) increasing with service
+ Annual leave purchase scheme (with 12 months service)
+ Company paid health cash plan
+ Long Service Vouchers
+ Cycle to Work Scheme
+ bhsf RISE - our Health and Wellbeing hub 24/7 access to GP's and Counsellors
+ Blue Light card - providing thousands of amazing discounts online and on the high street
**Who is Fresenius Medical Care?**
We are the **leading provider of dialysis services** to the NHS, operating **52 partnership dialysis units** that together provide regular dialysis treatment to over **3,800 NHS patients in the UK** . We are part of a global company treating over **344,000 patients worldwide** across **over 4,000 clinics** .
We also operate **44 production sites on all continents** to provide dialysis products such as dialysis machines, dialysers and related disposables. **1 in every 2 of all dialysis machines** used around the globe are manufactured by Fresenius Medical Care and we are the **3rd largest medical devices company in the world.**
**Regulatory Affairs Assistant posts will be subject to a Basic DBS Disclosure**
**Fresenius Medical Care is an equal opportunities employer**
Regulatory Affairs Specialist
Posted 4 days ago
Job Viewed
Job Description
We seek talented individuals who will contribute to and thrive in our collaborative, diverse, fast-paced environment while demonstrating a commitment to our core values, People, Customer, Results, Continuous Learning, and Innovation?
People - We win as a team?
Customer - We deliver customer-centric solutions?
Continuous Learning - We learn and always aim to be better?
Innovation - We innovate every day?
Results - Results matter for all of us.
Position Summary: This role manages the regulatory affairs function for Richard-Allan consumables and Shandon Diagnostic Instrumentation, ensuring regulatory compliance for Epredia's manufacturing site and device portfolios to support and maintain global market access. The Regulatory Affairs (RA) Specialist escalates all regulatory matters to the Global RA Director (Heather Gallacher) and is responsible for supporting global registration activities for instrument and consumable device portfolios.
What you will do:
Regulatory Support - Shandon Diagnostics & Richard-Allan Scientific:
+ Ensure regulatory compliance of the manufacturing site, supporting site operations accordingly.
+ Approve regulatory processes and documentation related to new product development, product changes, improvement projects, and marketing materials.
+ Support global product registration efforts for devices.
+ Prepare and maintain technical documentation including DoC, GSPR, and related files.
+ Contribute to the Health Hazard Assessment (HHA) process as part of Post-Market Surveillance (PMS) and Vigilance activities related to site complaints and quality issues.
+ Support the site's Quality Management System (QMS), including audits, regulatory SOPs, complaint investigations, and documentation/labeling review, approval, and release.
+ Lead regulatory activities for site projects, including new product development and manufacturing transfers.
+ Maintain regulatory intelligence at the manufacturing site s ; conduct training sessions as needed, including those on new regulations.
+ Complete EMEA registration requests for the instrument and consumable portfolio s (new and existing devices).
+ Complete or support registration requests across the entire Epredia portfolio, as needed
Qualifications & Skills:
+ Scientific degree with over 1 year of experience in In Vitro Diagnostic Medical Devices (IVDs).
+ Working knowledge of global regulations preferred (US FDA, EU IVDR, and Rest of World).
+ Spanish fluency (written and spoken) is beneficial not essential.
+ Strong attention to detail.
+ EMEA registration experience.
+ Clear and effective communication skills.
+ Ability to interpret and apply regulations to business-specific scenarios.
+ Competent in creating project plans, timelines, and regulatory strategies; skilled in organizing and tracking complex regulatory data.
+ Familiarity with ISO 13485 and global IVD regulations (US and EU).
+ Capable of managing multiple projects and competing priorities.
+ Exercises sound, ethical judgment within company policies and regulatory frameworks.
+ Willingness to travel internationally up to 10%.
TO ALL RECRUITMENT AGENCIES: Epredia does not accept unsolicited third-party resumes.
Building an Inclusive Culture: We are a company that brings the best people together and leverages their varying backgrounds, ideas, and points of view to invent on behalf of all customers. We are committed to equal employment opportunity for all individuals, without regard to race, color, national origin, ancestry, sex, age, religion, physical or mental disability, medical condition, veteran status, marital status, pregnancy, sexual orientation, gender identity, genetic information or any other protected classes which may exist under applicable federal, state or local law.
At Epredia, we improve lives by enabling better cancer diagnostics. We are a team of talented individuals with diverse backgrounds and expertise, working together to develop precision diagnostic solutions for our customers. We are a fast growing global company that drives innovation in diagnostics to create better outcomes for patients. Joining Epredia is much more than a job- it is an opportunity to be part of something with a purpose. Find out how you can improve lives while advancing your career.