Medical Device Regulatory Affairs Manager - Award Winning CRO

With corporate activities growing rapidly, our client are currently seeking a full-time Regulatory Affairs Manager to join their Regulatory Affairs team and to support their Medical Device business.

This position will involve the need to carry out responsibilities of the Office of Authorised Representative (AR), which will include:

• Verifying compliance on behalf of Clients with regulations, standards and guidance documents;
• Maintaining and developing processes and procedures in support of the role of European AR;
• Liaising with and responding to requests for information and/ or documentation from Competent Authorities (CA's).

Also, you'll be required to carry out responsibilities in support of full global regulatory submissions, which will include:

• Providing regulatory advice and guidance to Sponsors and departments to ensure compliance with regulations, standards and guidance documents;
• Developing scientific and regulatory briefing documents for meetings with the regulatory agencies and bodies;
• Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.

Benefits:

• Work for multi award Winning CRO
• Work with a range of pharmaeceutical clients and innovative new drug launches
• Play key role in drug launches and getting patients products they need
• Various internal growth opportunities as company expands
• Generous compensation and benefits package
• Take key leadership role in growing team
• Opportunity to travel to global office locations

Requirements:

• Bachelor's degree, preferably in the sciences, or equivalent experience qualification
• Significant medical device, in vitro diagnostic and/ or active implantable experience within Regulatory Affairs or in a similar role;
• Demonstrable experience, including document preparation and/ or writing, clinical trials, post-market activities and regulatory agency interaction;
• Knowledge of existing medical devices regulations is essential with knowledge of new medical device regulations being highly desirable;
• Experience with regulatory agencies and notified bodies is preferred;
• Strong computer skills, project management skills, and a high attention to detail;
• Strong communication skills (both written and oral);
• Must be a team player with a global regulatory mind-set.

Travel: Less than 15%

For a confidential discussion about this, please contact Edward Little on 0207 940 2749 (EXT: 7168) or send your updated CV in a word document to E.Little@nonstop-recruitment.com

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.