Regulatory Affairs Manager

Regulatory Affairs Manager

Excellent Package / South Wales

Our client is a leading UK manufacturer of medical devices. Backed by over 30 years experience in design and development, and supported by a modern manufacturing facility, they have built a world class reputation for the supply of medical devices. You will work within a purpose built plant covering 48,000sq feet, incorporating clean rooms, state of the art manufacturing equipment and warehousing facilities, which all combine to make a fast response to customer's demands

Reporting to the Quality, Regulatory and Technical Director, this role is responsible for the leadership and support of the Regulatory personnel. You will participate in all activities relating registration requirements and line extension indications

Key Tasks & Responsibilities:

• Keep up to date with market trends and new developments and utilise the information obtained for business improvement activities.

• Carefully plan to achieve accurate and timely results.

• Recognise recurring issues and analyse their causes in order to reach a solution.

• Coordinate & prepare regulatory submissions and strategies.

• Develop & maintain regulatory knowledge of European, FDA and country specific regulations.

• Manage the final product submissions and negotiate and communicate effectively with regulatory authorities to obtain timely product approvals.

• Participate in product teams with regard to implementation of regulatory requirements.

• Defend company business interest in international standardisation groups.

• Manage transposition of international standards into company product related requirements.

• Provide the Project Teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning

• Update licensing and collect information on registration instructions and regulations

Skills & Experience:

• A proven, demonstrable track record in a similar role for at least 5 years within the medical sector.

• Extensive understanding and experience of dealing directly with all relevant regulatory bodies.

• 10 years experience in a manufacturing environment with the complexities of the medical industry.

• First class competence in all aspects of Regulatory Affairs.

• Strong verbal & written communication skills.

• Professional, decisive and the ability to provide strong direction.

• Excellent people manager with a proven ability to achieve goals.

• Natural talent to network, build relationships.

• A driver, completer finisher and a strong sense of accountability.

• Excellent understanding of both verbal and numerical information and the ability to analyse information to make sound judgements and decisions.

• Able to set objectives to ensure that the team understands and achieves the specific KPIs, which fit in to the business plan.

• High degree of passion, enthusiasm, drive, commitment and determination with the ability to translate this to others in all relevant activities.