Global Medical Device Regulatory Strategist

Oracle; City Of London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A global tech company in the healthcare sector is seeking a Medical Device Regulatory Affairs Strategist. The role involves working with engineering teams to develop regulatory strategies and manage compliance for AI-enabled software applications in a fast-paced environment. Candidates with experience in medical device regulations and strong communication skills are preferred. Competitive compensation and opportunities for professional development are offered.

Qualifications

• Experience with SaMD in the medical device industry.
• Experience authoring regulatory submissions (510k, EU Tech Files).
• Ability to perform in a fast-paced environment.

Responsibilities

• Work with product engineering teams to develop regulatory strategies.
• Collaborate on managing pre-market submissions.
• Support internal and external audits for compliance.

Skills

Regulatory Affairs

Quality Compliance

Product Development

Communication Skills

Risk Management

Education

BA/BS or advanced degree

Tools

ISO 13485

ISO 14971

21 CFR parts 1000/1001

Job description

A global tech company in the healthcare sector is seeking a Medical Device Regulatory Affairs Strategist. The role involves working with engineering teams to develop regulatory strategies and manage compliance for AI-enabled software applications in a fast-paced environment. Candidates with experience in medical device regulations and strong communication skills are preferred. Competitive compensation and opportunities for professional development are offered.