Regulatory Affairs Manager - Medical Devices

Regulatory Affairs Manager
Are you ready to make a meaningful impact in the medical device industry?

A thriving global leader in fertility solutions is looking for a Regulatory Affairs Manager to guide and inspire a small team of specialists. This is more than a role-it's a chance to drive innovation in an expanding portfolio of cutting-edge fertility equipment and consumables, ensuring their success on the global stage.
This new position is integral to the growth of the fertility sector and offers a unique opportunity to shape strategies that meet regulatory requirements for international market access. You'll be part of cross-functional New Product Introduction (NPI) teams, collaborating on groundbreaking medical device developments.
Location:
Based in the UK, this role involves occasional travel (3-4 times a year) to a state-of-the-art manufacturing facility in the UK. Applicants must be eligible to work in the UK and travel visa-free within the EU.
What You'll Be Doing:

• Leading with Vision: Manage and mentor a talented team of regulatory specialists, fostering collaboration and professional growth.
• Driving Innovation: Oversee regulatory aspects of fertility medical devices and lab equipment, ensuring compliance across EU, US, and UK markets.
• Ensuring Compliance: Develop and maintain regulatory documentation for Class I, IIa, and IIb devices, including EU MDR technical files, US 510(k), and PMA submissions.
• Managing Change: Conduct regulatory impact assessments for device updates, processes, supply chains, and evolving regulations.
• Collaborating Across Teams: Serve as the regulatory advisor for NPI projects, from concept to delivery.

What You Bring:

• A Master's degree in Engineering, Biosciences, or a related field.
• 4+ years of experience in regulatory roles within the medical device industry.
• 3-5 years of managerial experience in an international setting.
• Deep knowledge of EU, US, and UK medical device regulatory requirements, including Class I, IIa, and IIb devices.
• Exceptional project management, organizational, and communication skills.
• Proficiency in MS Office and fluency in English (written and spoken).

What's in It for You?

• Competitive Salary: Reflecting your expertise and impact.
• Outstanding Benefits: Including a comprehensive package that supports your well-being and growth.
• A Collaborative Culture: Join a global team that values innovation, inclusivity, and professional development.
• Purpose-Driven Work: Be at the forefront of fertility technology, helping bring life-changing products to market.

Ready to Lead?
If you're a dynamic, results-driven professional who thrives on challenges and collaboration, this is your chance to make a real difference in the lives of families worldwide. Apply now to take your career-and this mission-to the next level.

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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