Cypartners
Medical Devices Regulatory Affairs Manager
Job Description
Step into a pivotal role as a Regulatory Affairs Manager focusing on medical devices at a dynamic organization in Oxfordshire. Drive FDA and EU submissions while ensuring compliance and strategic planning.
The Regulatory Affairs Manager will be responsible for managing regulatory submissions, including variations and renewals. Collaborate with cross-functional teams, ensuring all documentation meets FDA and EMA standards. Your expertise in regulatory compliance and drafting will be vital to the success of innovative medical devices currently in clinical trials.
Key Responsibilities:
• Develop submission strategies for market applications and variations
• Write and review compliant regulatory documents
• Ensure adherence to FDA and EMA requirements
• Collaborate with manufacturing and quality assurance teams
• Communicate with health authorities for submissions and inquiries
Requirements:
• In-depth regulatory knowledge of FDA and EU requirements
• Proficie...
The Regulatory Affairs Manager will be responsible for managing regulatory submissions, including variations and renewals. Collaborate with cross-functional teams, ensuring all documentation meets FDA and EMA standards. Your expertise in regulatory compliance and drafting will be vital to the success of innovative medical devices currently in clinical trials.
Key Responsibilities:
• Develop submission strategies for market applications and variations
• Write and review compliant regulatory documents
• Ensure adherence to FDA and EMA requirements
• Collaborate with manufacturing and quality assurance teams
• Communicate with health authorities for submissions and inquiries
Requirements:
• In-depth regulatory knowledge of FDA and EU requirements
• Proficie...