Medtronic UK is seeking a Regulatory Affairs Specialist to support design and development control activities, focusing on regulatory strategies for medical devices and pharmaceuticals. The ideal candidate should possess a relevant degree, 4-7 years of experience in regulatory affairs, and a strong understanding of global regulatory requirements
Job Summary
Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments.
Prepare, review, file, and support premarket documents for global registrations for assigned projects.
Medtronic offers a competitive Salary and flexible Benefits Package.
Matching Summary
Match Score: 85
Medtronic UK is seeking a Regulatory Affairs Specialist to support design and development control activities, focusing on regulatory strategies for medical devices and pharmaceuticals. The ideal candidate should possess a relevant degree, 4-7 years of experience in regulatory affairs, and a strong understanding of global regulatory requirements.
Skills & Requirements
Must-have
support design and development control
prepare and file premarket documents
develop regulatory strategies
monitor regulatory environment changes
communicate with health authorities
review change control documents
Nice-to-have
experience with cross-functional teams
experience solving problems
experience with project management
work well under pressure
highly organized and detail-oriented
team player
strong interpersonal and negotiation skills
Key Requirements
Bachelor's degree in medical, Mechanical, Electric Life Science or other healthcare related majors
4-7 years experience in medical device and/or pharmaceutical industry
Good understanding of India, US FDA and EU regulations
Excellent written, organizational, and communication skills
Strong attention to details and ability to handle multiple tasks