Regulatory Affairs Manager

14 hours ago


Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd Full time

Regulatory Compliance Specialist

A renowned healthcare technology company is seeking a highly motivated Regulatory Affairs Manager to lead their regulatory compliance efforts across international markets. This individual will play a critical role in guiding the organization's innovative medical products through the regulatory approval process, ensuring compliance with global quality standards.

This is an exceptional opportunity for someone who is passionate about navigating complex regulatory landscapes to bring cutting-edge technologies to market.

  1. Develop Regulatory Strategies: Create and implement effective regulatory strategies for all products across key international markets.
  2. Provide Regulatory Training: Ensure the team stays up-to-date on global regulatory changes and provides training on regulatory requirements.
  3. Oversee Regulatory Submissions: Lead the preparation and submission of regulatory applications, including FDA approvals, UKCA, and CE marking.
  4. Ensure Post-Market Compliance: Guarantee that post-market surveillance activities comply with all regulatory requirements.
  5. Manage External Relationships: Serve as the primary point of contact for communications with regulatory bodies, Notified Bodies, and reimbursement entities.
Responsibilities

As a Regulatory Affairs Manager, you will be responsible for developing and implementing regulatory strategies, providing regulatory training, overseeing regulatory submissions, ensuring post-market compliance, and managing external relationships.

ProTech Recruitment Ltd

We are a specialist recruitment agency serving the healthcare technology industry. Our mission is to connect talented professionals with exciting job opportunities that make a difference in people's lives. If you're passionate about bringing innovative products to market while ensuring the highest regulatory and quality standards, join us

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