Medical Device Regulation Regulatory Affairs Lead, Sports Medicine, Endoscopy (Smith & Nephew, Inc., Memphis, TN): Oversee line management of Medical Device Regulation (MDR) Regulatory Affairs Endoscopy team. Prepare and communicate submission/compliance strategy documents in addition to preparing and reviewing technical documentation including labelling and instructions for use and works with relevant cross-functional teams to resolve issues. Provide expert advice on understanding and implementing the MDR regulation to the endoscopy business team. Report compliance metrics and collaborate with the RA Franchise lead to plan and deliver submissions within specified timeframes. Host, manage and prepare for Notified body technical audits and respond to any related deficiencies. Communicate changes to global markets and provide submission deliverables to international regions. Approval of Technical Files and Design Dossiers. Provide training on regulatory requirements to endoscopy franchise team and act as a subject matter expert during this process. Development and maintenance of procedures and systems to ensure that the process addresses all regulatory requirements and business objectives. Monday – Friday, 40 hours per week.

MINIMUM REQUIREMENTS:

Must have a Bachelor’s degree in Biomedical Engineering, Regulatory Affairs, Pharmacy or a related life science degree plus 5 years of post baccalaureate experience in the job offered or related role in the medical device industry, OR alternatively, must have a Master’s degree in Biomedical Engineering, Regulatory Affairs, Pharmacy or a related life science degree plus 1 year of experience in the job offered or related role in the medical device industry.

Of the required experience, must have 1 year of experience in each of the following:

• Providing Regulatory Strategy Advice to cross functional business teams.
• EU Medical Device Regulations, CE mark process and industry standards.
• Management and development of team members.
• Preparation and review of technical file including labelling and instructions for use and work with relevant cross-functional teams to resolve issues.
• Host, manage and prepare for Notified body technical audits and respond to any related deficiencies.
• Communicate changes to global markets and provide submission deliverables to international regions.
• Development and maintenance of procedures and systems to ensure that the process addresses all regulatory requirements and business objectives.

Telecommuting permitted.

Must be willing and able to travel up to 14% national and 10% international.

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.