Head of Quality and Regulatory Affairs Specialist

3 weeks ago

Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter Full time

{"Lead Regulatory Strategy": "Develop and execute the regulatory strategy for all products across key international markets, ensuring compliance with global quality standards and regulatory requirements.

Provide regulatory guidance to the team, ensuring they are up-to-date on global regulatory changes and trained on regulatory requirements.

Oversee the preparation and submission of regulatory applications, including FDA approvals, UKCA, and CE marking, to ensure timely and successful regulatory submissions.

Ensure post-market surveillance activities comply with all regulatory requirements, serving as the key point of contact for communications with regulatory bodies, Notified Bodies, and reimbursement entities.

Additionally, the Head of Quality will manage the company's quality systems, including achieving ISO13485 certification and overseeing the Quality Management System (QMS), ensuring all staff are trained on and adhere to quality procedures.

This is an exceptional opportunity to drive the regulatory and quality functions of a company at the forefront of healthcare innovation, bringing life-changing products to market while ensuring the highest regulatory and quality standards.

Key Responsibilities:

* Develop and execute the regulatory strategy for all products across key international markets
* Provide regulatory guidance to the team
* Oversee the preparation and submission of regulatory applications
* Ensure post-market surveillance activities comply with all regulatory requirements
* Manage the company's quality systems, including achieving ISO13485 certification and overseeing the QMS

Requirements:

* Demonstrable experience with successful regulatory submissions, including FDA, UKCA, and CE marking applications for in vitro diagnostics
* Strong knowledge of global regulatory requirements and quality standards
* Excellent communication and leadership skills
* Ability to work in a fast-paced environment and prioritize multiple tasks

What We Offer:

* Competitive salary and benefits package
* Opportunity to work with a leading healthcare technology company
* Collaborative and dynamic work environment

If you are a motivated and experienced professional looking to drive the regulatory and quality functions of a company at the forefront of healthcare innovation, please submit your application.

We look forward to hearing from you"}

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