Senior Regulatory Affairs Specialist | Hybrid Submissions

Boston Scientific; Marlborough (MA); Hybrid; USD 89,200 - 169,500; Full time

Job summary

Boston Scientific is seeking a Senior Regulatory Affairs Specialist to provide regulatory support for development, sustaining engineering, and acquisition integration activities. You will develop regulatory strategies, prepare global submissions, and partner with cross-functional teams to ensure regulatory compliance throughout the lifecycle.

This hybrid role requires in-office presence at least three days per week, with potential bases in Marlborough, MA or Maple Grove, MN.

Qualifications

• Bachelor's degree in a scientific or technical field is required.
• Minimum 4 years' experience in Regulatory Affairs within medical devices.
• Experience with regulatory requirements for implantable or active implantable devices.
• Experience supporting product development and sustaining activities for implantable devices.
• Experience preparing regulatory submissions for medical devices.
• Experience with product development processes and design controls.
• Working knowledge of FDA, EU and international medical device regulations.

Responsibilities

• Provide technical guidance and regulatory training to Regulatory Affairs team members and cross-functional partners.
• Act as company representative, developing and maintaining relationships with device reviewers over submissions under review.
• Develop and implement regulatory strategies for new and modified products.
• Lead regulatory workstreams during product integration, coordinating team inputs for submissions.
• Review and approve design and manufacturing changes for regulatory compliance.
• Prepare and submit global regulatory applications, including US and EU MDR submissions.
• Review device labeling and advertising materials for regulatory compliance.
• Provide training on departmental policies and procedures.
• Support highly technical product lines, including integrations and sterilization processes.
• Participate in regulatory collaborations and alignment with other specialists.
• Foster continuous improvement aligned with Boston Scientific's Quality Policy and regulations.

Skills

Regulatory affairs

Regulatory strategy

Regulatory submissions

Device regulations

Product development

Design controls

FDA/EU/regulatory knowledge

Education

Bachelor's degree in a scientific or technical discipline

Tools

Microsoft Word

Excel

PowerPoint

Job description

Boston Scientific is seeking a Senior Regulatory Affairs Specialist to provide regulatory support for development, sustaining engineering, and acquisition integration activities. You will develop regulatory strategies, prepare global submissions, and partner with cross-functional teams to ensure regulatory compliance throughout the lifecycle.

This hybrid role requires in-office presence at least three days per week, with potential bases in Marlborough, MA or Maple Grove, MN.