The successful RA Specialist will be responsible for providing Regulatory support through the Design and Development and change control process. They will also plan, prepare and submit regulatory submissions. Provide support to company RA with all international country submissions. Support company goals and objectives, policies and procedures, quality systems, and FDA regulations
RA Specialist responsibilities:
- Identifying new regulations and standards that impact regulatory compliance
- Complete technical review, of manufacturing location process validation documentation in line with MDR requirements and update where required.
- Support Management review and Management of external 3rd party audits.
- Provide Regulatory support to new product introduction and product transfers teams.
- Plan, prepare and submit regulatory submissions for specific target markets for new products, product changes, and re-registration as needed or collaborates with their assigned regulatory specialists on same.
- Ensures the clinical requirements of the product are adequately addressed.
- Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
- Provides support to currently marketed products as necessary including input on change requests, etc.
- Maintains and organises appropriate Technical files and regulatory records to demonstrate compliance with applicable regulations.
RA Specialist Requirements:
- Level 8 degree in a relevant disciplne
- Previous regulatory experience in a similar work environment is essential.
- Experience in working Medical Device manufacturing Facility
- Strong computer skills – Change control management; design, process, and system.
- Familiarity with ISO quality systems (MDD 93/42/EEC/MDR – ISO13485 – 21 CFR 820)
- QMS Internal auditing skills
- Good customer relation skills
- Ability to present an independent opinion