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| Senior Regulatory Affairs Specialist | EU | Not Disclosed |
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Regulatory Affairs Director Career Profile
Regulatory Affairs Director
A strategic role which is responsible for the overall direction of the company, often involved in a smaller company at start-up stage. The spec below refers to an example position in the Medical Device sector
Key Responsibilities
- Compliance with and adherence to medical device regulations in the geographical areas mentioned.
- Achieve approval for these 2 products to be sold in new territories, in accordance with Class III Medical Device regulations.
- Introduce and managed design control and quality systems.
- Regular meetings with other territories, to collaborate on solutions and current progress. Included in this will be frequent air travel.
- Dealing directly with relevant local regulatory bodies.
- Managed Customer Complaints though extensive consultation with physicians and Sales and Marketing personnel.
- Assisting with research and seeking regulatory approval in relation to possible other clinical indications of the products in various markets.
- Authored and deliver product presentations to physicians and to sales personnel.
- Liaise with international colleagues in relation to ongoing clinical monitoring.
Skills / Experience
- B.Sc. degree in Life Sciences, advanced degree preferred.
- 10+ years experience in Medical Device Regulatory Affairs, specifically dealing with emerging geographical markets. 4 years in a senior management capacity, preferably internationally.
- Knowledge of GI / urinary diseases.