Senior Regulatory Affairs Specialist

About the role

Boston Scientific is looking for a Senior Regulatory Affairs Specialist to join its Interventional Therapies Division. The role covers regulatory strategy, submissions and compliance for product and manufacturing changes, with a hybrid workplace combining working from home and onsite work.

Key responsibilities

• Review complex product and manufacturing changes for regulatory compliance, assess their impact on regulatory submissions and define the appropriate regulatory strategy.
• Liaise with international regulatory colleagues on product and manufacturing changes, global regulatory strategy and international submissions.
• Lead the coordination, writing and submission of U.S., EU and international regulatory submissions for modified products and manufacturing changes.
• Develop and implement regulatory strategies to support regulatory approvals and continued market access.
• Maintain EU MDR Technical Documentation and give regulatory guidance to ensure compliance throughout the product lifecycle.
• Represent regulatory affairs on cross-functional project teams, identify regulatory risks and influence project decisions.
• Support and lead interactions with regulatory authorities and Notified Bodies.
• Provide regulatory guidance, training and mentoring to less experienced team members and take part in corporate and department training.

Required profile

• Bachelor's degree or related field.
• 4+ years of regulatory affairs or related experience.
• Ability to evaluate complex product and manufacturing changes, determine regulatory impact and recommend strategies.
• Ability to lead cross-functional collaboration and manage multiple complex projects in a timeline-driven environment.
• Advanced English level.

Required skills

• Microsoft Word, Excel, PowerPoint and Adobe Acrobat.
• Regulatory submissions and EU MDR technical documentation.