Director Regulatory Affairs

Additional Locations: Netherlands-Kerkrade; France-Voisins le Bretonneux; France-Île-de-France; Germany-Aachen; Germany-Duisburg; Germany-Düsseldorf; Germany-Köln; Germany-Ratingen; Germany-Wiesbaden; Ireland-Clonmel; Ireland-Cork; Ireland-Galway; Ireland-Kerlogue; Italy-Milan; Netherlands-Eindhoven; Netherlands-Maastricht; Poland-Warsaw; Spain-Madrid; Switzerland-Basel; Switzerland-Bern

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.

About the role:

The role is a critical link in the executive management team for the EMEA region (80+ countries – regulated and non-regulated markets (pre- and post-market)) and in the Regulatory Affairs (RA) and Quality Assurance (QA) divisional and global management groups within Boston Scientific. 

Your responsibilities include:

• Develop and provide regional regulatory strategy and leadership in collaboration with the divisional and global organizations.
• Lead and develop the EMEA RA organization to meet the functional and business goals.
• Proactively build trusted relationships and negotiates with Competent Authorities/ Health Authorities/ Notified Bodies.
• Responsibilities for product submissions/approvals, both direct or via distributor/local consultant.
• Implement procedures and policies to ensure regulatory compliance within the business environment.
• Act as the EU Authorized Representative (AR) primary contact point and complete all required EU AR approvals. 
• Act as the UK Responsible Person (post-Brexit), act as the Swiss AR.
• Coordinate escalations from EMEA regulatory bodies, including collaboration with outside counsel, regulatory agency meetings and Notified Bodies where applicable.
• Participate in assessment of new/evolving regulations and gap/impact assessment.
• Support Product Inquiry Reports (PIRs), field action activities and related Additional Information (AI) requests for EMEA.
• Participate in the EMEA vigilance forum and partner with Post Market Quality Assurance on related AIs/market surveillance activities, including regulator “signals”.
• Participate in advocacy activities both within EMEA and via Global Advocacy Forum.
• Close collaboration with the Global Quality Systems, Global RA Operations and Global RA Advocacy team on major regulation and technology changes.
• Support/drive Value Improvement Program initiatives for region/function.
• Support acquisition, digital health and clinical study activities from a RA perspective for EMEA.
• Proactively provide regulatory guidance, support and expertise throughout the Boston Scientific organization.
• Monitor, interpret, and communicate regulatory expectations to internal and external stakeholders in order to execute program objectives in compliance with applicable regulations.
• Provide counsel, training, and interpretation of regulatory requirements.

What we are looking for: 

• Master’s degree preferred or Bachelor's degree plus 9-12 years of related work experience or an equivalent combination of education and work experience
• 6-8 Years of experience leading a team
• Master’s degree in related technical field
• Proven track record of direct experience in interfacing with notified body (NB), Competent Authorities (CA) and Health Authorities
• Extensive knowledge of EU Regulatory environment (including EUMDR transition) and experience with working with EU legislation and regulators
• Strong knowledge of EU and other applicable international regulatory requirements including clinical trial requirements, quality system requirements, submission requirements, labeling and promotion requirements
• Strong leadership skills and demonstrated experience leading and developing team members
• Strong communication, negotiation, and collaboration skills with the ability to successfully interact at all global levels of the organization
• Champion in Diversity Equity &Inclusion/Talent & Culture activities
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
• Self-motivated, independent worker

Requisition ID: 557004

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!