Regulatory Specialist - Contract

Frey Consulting Group; United Kingdom; Remote; GBP 40,000 - 60,000; Full time

Job summary

An innovative consulting firm is seeking a freelance Senior Regulatory Specialist to drive global medical device registrations. In this pivotal role, you will monitor regulatory changes, liaise with stakeholders, and ensure compliance with medical device standards. Your expertise will guide the development of regulatory strategies for new products, while you also manage technical documentation and lead audits. This position offers the flexibility of remote work, allowing you to contribute significantly to the success of medical devices in the market. If you have a passion for regulatory affairs and a track record in medical device registrations, this opportunity is perfect for you.

Qualifications

• Thorough experience in medical device product registrations is essential.
• Experience in regulatory strategy and compliance is highly valued.

Responsibilities

• Monitor and analyze regulatory changes for compliance.
• Prepare and submit regulatory reports to authorities.
• Lead audits and manage regulatory affairs coordination.

Skills

Medical Device Regulations

Regulatory Strategy Development

Clinical Evaluations

Technical Documentation Management

Stakeholder Liaison

Education

Bachelor's Degree in Life Sciences

Master's Degree in Regulatory Affairs

Tools

Regulatory Compliance Software

Document Management Systems

Job description

Senior Regulatory Specialist – Freelance

Our client is looking for a freelance Senior Regulatory Specialist for a full-time contract focused on global medical device registrations.

Location: Remote

Position: Senior Regulatory Specialist/Manager

Focused on product registrations of Class IIa/IIb medical device products, globally.

In addition, as an extended member of the development project team, the successful RA Specialist will have input into regulatory plans for new products.

Full role responsibilities include:

1. Monitoring & analysing regulatory changes and implementing strategies for meeting new and changed requirements
2. Liaison with internal and external stakeholders, providing training and support to ensure that regulatory requirements are met
3. Preparing and submitting pre- and post-market reports to regulators and local representatives
4. Planning and performing clinical evaluations of the company’s medical devices
5. Maintaining Technical Documentation and ensuring that the company’s compliance with applicable standards, regulations and guidance is documented
6. Acting as a lead auditor of internal functions and external suppliers
7. Line manager/supervision for the Regulatory Affairs Coordinator

The ideal applicant:

Our client is looking for a Senior RA Specialist or Manager with thorough experience of medical device product registrations including via distributors.