RA Manager, Global Regulatory Systems

Full Job Description

JOB TITLE : RA Manager, Global Regulatory Systems

LOCATION : Fareham/Hybrid or Rochester, NY/Hybrid

WORKING HOURS : 37.5, Monday to Friday

A brighter future awaits you.

At CooperVision, we are proud to be the global leader in contact lenses. At our innovative sites worldwide, we manufacture and distribute contact lenses to some of the biggest names in optics. We’re all about creating brighter futures for our customers, our wearers and our people. 

What can you expect from us as an employer? Well, we like to look at things a little differently. We call it bringing a refreshing perspective. And for every one of us who works here, it means our opinion really counts, we get to share our ideas, and we get to make an impact.  

We’re big on belonging. Because being part of something great is what makes our company the best it can be. And we value diversity, because you can see a whole lot more when you have different perspectives. We’re an ambitious company. And to help us achieve our goals, we’ll give you all you need to achieve yours.  

What will you be doing:

The Global Regulatory Systems Manager will be involved in managing, implementing and improving global regulatory systems and processes in support of global and regional regulatory activities. The Global Regulatory Systems Manager will also work with Global and Site Quality to ensure that the activities of the regulatory affairs function are embedded in the Quality Management System, and subject to appropriate oversight and improvement mechanisms. 

Consistent with the corporate values and quality policy and procedures, the Global Regulatory Systems Manager is responsible for exhibiting and demonstrating professional integrity and collaboration with internal and external business associates that reflects positively on CooperVision.

Essential responsibilities: 

• Leads the implementation and improvement of regulatory affairs processes, including systems relating to the Regulatory Information Management system, the availability of technical documentation in support of global product submissions and registrations, and Unique Device Identification (UDI) management.
• Leads the Regulatory Systems team and ensures that all necessary HR process requirements are fulfilled.
• Liaises with third party system vendors as appropriate, including ensuring that related Supplier Quality processes are adhered to.
• Leads the development of procedures and training on regulatory systems.
• Liaises across the business to ensure that regulatory systems and processes are embedded in the Quality Management System and subject to appropriate oversight and improvement mechanisms.
• Partners across the regulatory affairs function to ensure that adequate training and support is given to regulatory affairs team members on relevant QMS processes.
• Supports the investigation into issues identified through regulatory processes, utilizing QMS processes as appropriate.
• Leads the development of processes required to ensure that technical documentation is made available to regulatory affairs as required in relation to product submissions and registrations.
• Partners with R&D and QA Operations on the establishment of sources of technical documentation and the embedding of technical documentation requirements within the QMS.
• Monitors the timely completion of investigations into issues identified with or through regulatory systems, liaising across functions as required.
• Develops metrics related to regulatory systems for routine monitoring and escalation to management review.
• Maintains comprehensive, audit-ready records of activities as required by the QMS.

What are we looking for?

• Minimum three years of experience in a regulatory or quality engineering role in the medical device or pharmaceutical industry.
• Prior experience communicating with regulatory authorities or notified body personnel.
• RAPS Regulatory Affairs Certification or ASQ CQE/CQA certification preferred, but not essential.

In addition, you’ll have experience in:

• Able to effectively lead cross-functional discussions and drive projects to completion. Educates others on regulations and company policies and procedures.
• Self-starter able to manage workload with minimal supervision.  Monitors and incorporates regulatory agency feedback and maintains current state-of-the-art. Seeks direction where required.
• Knowledge of U.S., E.U., Canadian, and other applicable laws and regulations pertaining to medical devices.
• Intermediate skill in the use of standard Microsoft Office suite applications. Database and flowcharting experience preferred.
• Effective verbal and written communication skills in a logical and concise manner. Able to communicate to varying audiences. Consistently reinforces regulatory expectations and requirements. 
• Ability to engage varied cultural and regulatory backgrounds worldwide with appropriate sensitivity.
• Able to understand manufacturing and supply chain processes. Capable of conducting effective root cause analysis and evaluating corrective action plans.
• Demonstrated ability to manage multiple competing priorities and maintain progress on all projects.

What we offer

You’ll receive competitive compensation and a fantastic benefits package including bonus, 25 days holiday, pension scheme, healthcare cover, life assurance, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more!

If you like what you see, take the first step towards your brighter future and apply today. All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.

What is important to us

Our four values define and underpin our unique culture; we are dedicated , we are inventive , we are friendly , and we are partners . Becoming part of the CooperVision family means joining a friendly team that’s open, flexible, and respectful of each other’s differences, working together to achieve something amazing. 

Recruiting, retaining, and promoting a diverse mix of employees is core to our success. It helps bring different perspectives, diverse conversations, and new ideas to the table, all of which are incredibly valuable.

At CooperVision we celebrate, not only our company success, but we celebrate who we all are individually, and we embrace diversity. We support and we encourage you to bring your full self and not just part of you. We are committed to each individual and we look forward to a Brighter Future together.

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $99,376.00 and $141,996.00 and may include cost of living adjustments.  The actual base pay includes many factors and is subject to change and modification in the future.  This position may also be eligible for other types of compensation and benefits.