Job Reference: J5632331
Updated On: 11/11/2019
Status: Now Interviewing
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Director Regulatory Affairs - Companion Diagnostics
Role OverviewHyper Recruitment Solutions have teamed up with a growing Global Biotechnology company to identify an experience Regulatory professional with exposure to Companion Diagnostics to join them as Director of Regulatory Affairs. As the Director Regulatory Affairs you will be responsible for all Regulatory activities relating to In-Vitro Diagnostic ( IVD ) Medical Device products.
You will report directly to the VP of Regulatory Affairs and lead the development of Global Regulatory strategy for diagnostic products that aligns with the commercialisation of Cell and Gene Therapy products.
This position is a fantastic opportunity to join a developing company where you will have the opportunity to build a team around yourself to influence the successful commercialisation of ATMPs.
Key Duties and ResponsibilitiesYour duties as the Director Regulatory Affairs - Companion Diagnostics will be varied however the key duties and responsibilities are as follows:
1. Develop Regulatory strategy for diagnostic IVD products to assist with the commercialisation of Cell and Gene Therapy products. You will develop strategy for both EU and US markets and act as the internal subject matter expert for Companion Diagnostics.
2. Manage Regulatory activities for Medical Device submissions including but not limited to CE Marks, EU/US Premarket Approvals ( PMAs ), 510(k)s, post approval reports and registration and device listings.
3. Act as lead and main point of contact for Regulatory Authorities such as the CDRH (part of FDA), CLIA and Notified Bodies.
4. Maintain technical files as well as keeping up to date Regulatory changes to ensure the internal leadership team and stakeholders as informed.
Role RequirementsTo be successful in your application to this exciting opportunity as the Director Regulatory Affairs - Companion Diagnostics we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (E.g. Biology, Biotechnology, Medical Devices, Engineering etc.) in addition to extensive Regulatory Affairs experience of Medical Device products, ideally IVDs.
2. Proven industry experience in working with EU markets where US exposure is a benefit where you have lead the submission of CE-Marking, clinical trial notifications, IDE, 510(k) and PMA submissions. Knowledge of IND, BLA, CTA and MAA submissions is beneficial.
3. A working knowledge and practical experience with of leading a team is beneficial where you have line manage staff directly or through project management. Experience of budget management is preferred but acting as a lead on projects where you have directly liaised and lead meeting with Regulatory bodies and authorities is vital for this role
Key Words: Regulatory Affairs | Director | Lead | Medical Devices | Combination Products | Companion Diagnostics | IVD | In Vitro Diagnostics | EU | US | FDA | EMA | Notified Bodies | CE Marking| 510(k) | PMA | Submission | Strategy | ATMP | Cell Therapy | Gene Therapy
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