Regulatory Affairs Director

• 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.

• 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.