Senior Regulatory Affairs Manager EMEA

Additional Locations: France-Île-de-France; Germany-Düsseldorf; Italy-Milan; Netherlands-Kerkrade; Spain-Madrid; United Kingdom-Hemel Hempstead

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Senior Regulatory Affairs Manager EMEA

As Senior Regulatory Affairs Manager, you will lead the Post-market Center of Excellence (CoE) for the EMEA region, ensuring compliance with regulatory requirements and supporting regulatory aspects of post market activities in EMEA for Boston Scientific. In this role, you will ensure compliance, drive process improvements, enhance the efficiency of the CoE, and play a pivotal role in building strong relationships with competent authorities and internal stakeholders.

Key Responsibilities:

• As PRRC to the EU authorized representative, oversee post-market regulatory activities for EMEA, including to EU MDR and other applicable regulations :
  • Coordinate and oversee timely reporting of Field actions to competent authorities (CA) within the EMEA region
  • Coordinate and oversee timely and accurate responses to regulatory inquiries after vigilance or field actions reporting.
• Key stakeholder in FA process activities such as regional regulatory assessment of PIR,  and customer letter drafting
• Cross-functional collaboration (notably with Field Action team, Quality, Divisions and within EMEA ) to ensure a comprehensive streamlined approach to post-market regulatory activities
• Lead and mentor the EMEA PMS CoE team
• Drive process efficiency across the EMEA region by assessing and optimizing current post market processes, and implementing new, innovative ways of working to enhance effectiveness and collaboration.
• Regulatory Intelligence and advocacy for regulatory aspects of post market activities within EMEA
• Build and maintain strong, collaborative relationships with CA in EMEA, acting as a trusted point of contact to address post market compliance matters.
• Support internal and external audits and regulatory inspections related to post market activities, with a focus on audit readiness

Qualifications:

• Bachelor’s degree in a scientific or technical field is ideal; advanced degree preferred.
• Minimum of 10 years of Regulatory Affairs experience, with a focus on post market activities in the medical device industry.
• Minimum of 3 years of people leadership experience 
• Expertise in EU MDR, FDA regulations, ISO 13485, and global post market requirements.
• Demonstrated experience in leading global and regional process improvement initiatives in Regulatory Affairs.
• Proven ability to build and maintain effective relationships with competent authorities, fostering trust and collaboration.
• Leadership experience, including a track record of managing and developing high-performing teams.
• Strong communication, analytical, and problem-solving skills, with a focus on delivering measurable outcomes.
• Ability to balance multiple priorities in a fast-paced, dynamic environment while maintaining a commitment to quality and efficiency within a large matrix organisation

Requisition ID: 598128

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!