Our client has a fantastic opportunity for a Senior Regulatory Officer. Reporting to the Quality Manager the successful candidate will be responsible for supporting all regulatory team members. They will lead key elements of regulatory systems, ensuring compliance to relevant standards for the business including ISO13485 and FDA QSR. Also the candidate will have the opportunity to work one day from home for the first 3 months, this will increase to 2 days working from home after that stage.
Main Duties:
- Drive quality culture in accordance with our quality policies, guidelines and processes
- Champion compliance to applicable Global Regulations and standards (eg. US FDA, 21 CFR 820, ISO and IVDR: In Vitro Diagnostics Regulation)
- Collaborate with the regulatory manager on all new IVDR regulations
- Support implementation of company regulatory strategies and providing guidance and expertise.
- Compiling and communicating regulatory requirements and gap analysis assessments (e.g. EU IVDR, global markets, standards, etc.) to multi-functional groups in a concise and precise manner.
- Review and approve the project documentation (risk management documentation, design reports, labelling, etc.).
- Ensure that updates to the Technical Files and international registrations are conducted appropriately.
- Communicate with relevant departments should any issues arise
- Ensure employees understand their duties/delegated tasks
- Provide coaching and support to all regulatory team
- Ensure any goals/deadlines are on target/being met
Essential Criteria:
- A minimum BSc in molecular biology or related discipline and/or a minimum 5 years’ experience in a regulatory role
- Min 2 years’ experience in a Medical Device or an In Vitro Diagnostic Company
- Working knowledge of ISO 13485 and ISO 14971 standards
- Experience with Post Market Surveillance and Vigilance activities
- Ability to work to tight deadlines
- Good initiative and team player
- Excellent communication and interpersonal skills
- Full clean driver’s licence.
Desirable Criteria:
- MSc in molecular biology or related discipline
- Experience in preparation of medical device technical files and regulatory submissions
- MDD/MDR experience and/or IVDD/IVDR experience
- Experience with QMS and product audits from Notified Bodie
Additional Benefits (After Probationary Period):
- Pension 5% Employee/ 5% Employer
- Death in Service
- Income Protection from week 14 to age 65
Skills:
ISO 13485 ISO 14971 FDA QSR
Benefits:
36.5hr Working Week Sports & Social Onsite Parking Confidential Counselling Services Hybrid
