Senior Regulatory Affairs Lead — Global Submissions & Strategy (Hybrid)

Boston Scientific Corporation; Saint-Denis; Hybride; EUR 75 000 - 110 000; Plein temps

Résumé du poste

Boston Scientific Corporation is seeking a Senior Regulatory Affairs Specialist to lead complex regulatory submissions and strategies for EU and international changes. You will coordinate cross-functional teams, maintain EU MDR Technical Documentation, and guide project decisions with regulatory insight.

Hybrid role with opportunities to work from home and onsite. A bachelor’s degree and 4+ years in regulatory affairs are required, along with advanced English and strong communication skills.

Qualifications

• Bachelor's degree or related field required.
• 4+ years regulatory affairs or related experience.
• Advanced submission and presentation software skills (Word/Excel/PowerPoint/Adobe Acrobat).
• Advanced English level and communication skills.

Responsabilités

• Coordinate and write US, EU and international regulatory submissions for modifications.
• Liaise with global Regulatory Affairs teams on product and manufacturing changes for submissions and regulatory strategies.
• Develop and implement regulatory strategies to support changes and continued market access.
• Maintain EU MDR Technical Documentation and ensure lifecycle compliance.
• Lead cross-functional teams, identifying regulatory risks and influencing decisions.
• Provide regulatory guidance and mentorship to junior team members.

Connaissances

Regulatory affairs

Cross-functional collaboration

Regulatory submissions

Regulatory strategy

Communication

English proficiency

Formation

Bachelor's degree

Outils

Microsoft Word

Excel

PowerPoint

Adobe Acrobat

Description du poste

Boston Scientific Corporation is seeking a Senior Regulatory Affairs Specialist to lead complex regulatory submissions and strategies for EU and international changes. You will coordinate cross-functional teams, maintain EU MDR Technical Documentation, and guide project decisions with regulatory insight.

Hybrid role with opportunities to work from home and onsite. A bachelor’s degree and 4+ years in regulatory affairs are required, along with advanced English and strong communication skills.