Director, NPI Regulatory Affairs — Global Compliance Leader

CooperCompanies; Eastleigh; On-site; GBP 80,000 - 120,000; Full time

Job summary

A leading medical device manufacturer is seeking a Director of Regulatory Affairs - NPI to lead regulatory strategies for new and revised products. The role involves providing strategic input, ensuring compliance, and overseeing the Regulatory Affairs team to facilitate product launch in global markets. Candidates should have extensive experience in regulatory affairs, particularly within medical devices, strong leadership capabilities, and a commitment to fostering an inclusive workplace culture. This position is based in Eastleigh, UK.

Benefits

Competitive compensation

Car allowance

Bonus

Private medical insurance

25 days holiday

Pension scheme

Access to Wellness Platform

LinkedIn Learning access

Qualifications

• Minimum 15 years' experience in medical devices regulatory affairs.
• Minimum 8 years in a leadership role across multiple countries.
• Strong knowledge of international business and regulatory environments.

Responsibilities

• Lead the development and execution of regulatory strategies.
• Ensure integration of regulatory requirements into design and development.
• Provide strategic insight to the R&D Senior Leadership Team.

Skills

Leadership skills

Knowledge of EU and US FDA regulations

Analytical evaluation and critical thinking

Excellent communication skills

Project management skills

Fluent English

Education

Bachelor's degree (BA/BSc)

MA/MSc or higher degree

Tools

Microsoft Office

Quality Management Systems

Job description

A leading medical device manufacturer is seeking a Director of Regulatory Affairs - NPI to lead regulatory strategies for new and revised products. The role involves providing strategic input, ensuring compliance, and overseeing the Regulatory Affairs team to facilitate product launch in global markets. Candidates should have extensive experience in regulatory affairs, particularly within medical devices, strong leadership capabilities, and a commitment to fostering an inclusive workplace culture. This position is based in Eastleigh, UK.