Jobs in Derby, United Kingdom

Regulatory Affairs Manager (EMEA)

Job Location: Remote, GBR

Job Requisition ID: 14232

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.

The Regulatory Affairs Manager (EMEA) provides direct support to Solta operations for their globally distributed products. They work closely with global regulatory affairs peers, Quality, R&D, and Operations to support EMEA licensing and registrations, and to ensure the effective execution and management of changes. They also serve as the primary contact for EMEA regulatory intelligence for the regulatory department. The key responsibilities include, but are not limited to:

• Collaborating with Solta's global regulatory teams in developing regulatory strategies for new product launches and obtaining regional product approvals in a timely manner for EU and Middle East markets.
• Serve as the primary contact for EMEA regulatory intelligence, proactively search and monitor policy, regulation, guidance and standard changes from health authorities; lead cross-functional teams to analyze the impact of regulatory environment changes on the company's products and business, and update key stakeholders in a timely manner.
• Summarize and provide regional regulatory intelligence reports periodically.
• Coordinate and lead interaction with regional authorities and Notified Bodies.
• Interpret regional regulations, standards, guidance, and registration requirements; provide regulatory guidance to and collaborate with Solta's global regulatory affairs team.
• Provide regulatory input and assessment for new product introduction (NPI) and maintenance of business (MOB) projects.
• Manage and monitor the performance of EMEA registration agencies and local distributors in terms of compliance.
• Create and maintain local regulatory databases including but not limited to EUDAMED.
• Review and approve advertising, promotional materials and labeling to ensure regulatory compliance.
• Represent regional RA in the drafting and maintenance of global and local RA related SOPs/WIs.
• Provide strong support to commercial, supply chain, QA teams, etc.
• Support internal and external audits/inspections as required.

• Bachelor degree or above in engineering, life science, or mechanical discipline.
• Minimum 6-8 years of regulatory affairs experience in a multinational company; regulatory knowledge of other countries/regions is a plus.
• Strong technical skills related to active medical devices; in-depth understanding of EU MDR; experience with laser, RF, or ultrasound device registration is a plus; aesthetic device experience is a plus.
• Expertise and experience in regulatory intelligence and regulatory database management including but not limited to EUDAMED.
• Good interpersonal skills, team player with the ability to work independently in a fast-paced and dynamic environment.
• Fluency in written and spoken English.
• Remote work eligibility (#LI-REMOTE).

We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.