Senior Regulatory Affairs Specialist
1 month ago
Senior Regulatory Affairs Specialist - Medical Device
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.
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