The Consultancy was founded in the 90s and provides cost-effective regulatory affairs consulting services to small and medium- sized medical device manufacturers and distributors seeking to import their medical devices into the European Union. The Consultancy services include EU Authorised Representative, Technical Files, Internal Audits, CE Marking,and Medical Device Registration with the MHRA.
KEY PURPOSE OF THE ROLE:
To provide both Medical Device Regulatory and Quality Management consultancy clients and prospective clients.
Fully support the Managing Director
Maintain clients CE Technical Files
RESPONSIBILITIES OF THE ROLE:
- To provide accurate and current medical device regulatory and quality management advice to all client base and prospective clients.
- Prepare, review and approve data elements for use in regulatory technical files in accordance with UK/EU/US requirements for medical devices and IVD's along with liaising with external regulatory authorities to ensure approvals are obtained in line with project schedules
- To perform visits to clients premises (or other location at client's request) to conduct regulatory/ quality meetings, audits, or other relevant regulatory requirement.
- To provide support to other members of the team and Managing Director, when requested.
- Oversea regular communication with clients so as to provide accurate and concise updates on regulatory changes that could affect their businesses.
- To ensure they comply with company's ISO 13485 accreditation.
- To represent the company in a professional and courteous manner.
- Any other task as required by the Company Directors.
Qualifications & Experience
- Degree or equivalent certification in science related, medical, or engineering discipline.
- Substantial regulatory experience within the medical devices sector (at least 7 years experience) ie Manufacturing and/or Consultancy
- Substantial experience in the compilation and review of Class I, IIa, IIb and III EU technical documentation for CE marking plus experience with 510k file compilation and submission to FDA. In particular with Clinical Evaluation compilation to current MEDDEV guidance and Risk Management implementation to medical device standard ISO 14971
- Suitable general IT skills
- Comprehensive understanding and Implementation of ISO 13485, FDA 21 CFR Part 820, Canadian ISO 13485 into quality management systems from inception and to upgrade existing systems and knowledge of MDSAP
- Knowledge of electrical and software safety standards.
- Internal/Supplier Auditing experience.
- Report writing skills