Boston Scientific Senior Regulatory Affairs Manager EMEA 

France, Paris 

176589266

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

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.

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