Regulatory Compliance Specialist

Full Job Description

Regulatory Affairs Custom Device Team Lead / Senior Regulatory Affairs Custom Device Associate

Main Purpose of Job and Objectives:

• Perform Regulatory tasks to ensure compliance with regulations.
• Prepare regulatory documentation and submissions for product approvals.
• Develop regulatory plans/strategies for new products and changes to existing products.
• Participate in Design Control and Risk Management activities.
• Review and prepare regulatory paperwork in accordance with international standards and regulations.
• Review product packaging, labelling, IFUs, and marketing literature for compliance.
• Facilitate compliance with Vigilance System.
• Provide regulatory input to functional groups.
• Participate in the review of RA procedures.
• Review and approve validation protocols and reports.
• Mentor RA Associates.
• Facilitate in the compilation, communication, and monitoring of FSN and recalls.
• Perform other duties as required by the RA department.

Dimensions & Limits of Authority:

• Must work within the requirements of the company handbook and policy statements.
• Maintain awareness of the relevance and importance of activities performed and how they contribute to quality objectives.
• Ensure accurate completion of records and report any quality issues to the immediate supervisor.
• Ensure facility, processes, and documentation remain in a state of audit readiness.

Qualifications & Experience:

• Experience in team/project management/custom-made devices is desired.
• Experience with quality engineering and/or MDR is required.
• Able to communicate effectively with external parties such as customers and distributors.
• Able to communicate effectively with personnel in QA/R&D and other departments.

Company Requirements:

• Must adhere to the company handbook and policy statements.

Quality Requirements:

• Maintain awareness of how activities contribute to quality objectives.
• Work within the Quality Management System at all times.
• Ensure accurate completion of records and report any quality issues to the immediate supervisor.
• Ensure facility, processes, and documentation remain in a state of audit readiness.

EH&S Requirements:

• Take care of your own health and safety and that of others who may be affected by your actions.
• Work cooperatively to highlight issues affecting Health and Safety.