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
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Compliance with and adherence to medical device regulations in the geographical areas mentioned.
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Achieve approval for these 2 products to be sold in new territories, in accordance with Class III Medical Device regulations.
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Introduce and managed design control and quality systems.
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Regular meetings with other territories, to collaborate on solutions and current progress. Included in this will be frequent air travel.
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Dealing directly with relevant local regulatory bodies.
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Managed Customer Complaints though extensive consultation with physicians and Sales and Marketing personnel.
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Assisting with research and seeking regulatory approval in relation to possible other clinical indications of the products in various markets.
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Authored and deliver product presentations to physicians and to sales personnel.
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Liaise with international colleagues in relation to ongoing clinical monitoring.
Skills / Experience
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B.Sc. degree in Life Sciences, advanced degree preferred.
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10+ years experience in Medical Device Regulatory Affairs, specifically dealing with emerging geographical markets. 4 years in a senior management capacity, preferably internationally.
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Knowledge of GI / urinary diseases.