16793 Senior Regulatory Affairs Specialist - Corp.

Job Description: At Boston Scientific we believe in innovation and collaboration - join us! As a leader in less-invasive medical technologies, Boston Scientific is looking to hire motivated professionals looking for new challenges. We are currently searching for a Senior Regulatory Affairs Specialist to join our Corporate team in Natick, MA.

Senior Regulatory Affairs Specialist

Key Responsibilities:


Act as a liaison to the Divisions as needed to facilitate interpretation and application of BSC policy and procedures

Provide expertise and guidance in interpreting regulations and agency guidelines

Create, modify, and implement corporate policy and procedures

Research as necessary and keep abreast of all domestic and international regulatory regulations, approval processes, current industry practices, standards and changes.

Identify, create, and implement RA training to cross-divisional and cross-functional groups

Review corporate labeling and advertising materials

Act as a core team member for corporate projects

Assist Divisions in submission writing as needed

Develop corporate communication materials as required

Other responsibilities as assigned



Qualifications:


Bachelor's degree or equivalent work experience, preferable in a scientific or technical discipline

Professional certification(s) preferred

5-8 years Regulatory Affairs medical industry experience

Thorough understanding of FDA and international regulations - thorough knowledge of PMA, IDE, 510(k), EU, and Japan submissions

Strong working knowledge of medical devices, procedures and terminology

Working knowledge of clinical trial strategy and study design, statistical methods and data reporting preferred

Working knowledge of product development process and design control.

Effective research and analytical skills

Proficiency with Microsoft Office

Ability to manage multiple projects

Excellent written and oral communication, technical writing, and editing skills

Ability to work independently with minimal supervision.

Searchable Keywords: 16792 Senior Regulatory Affairs Specialist - Corp. / gj-mo

Minimum Education Required: Bachelor

Years of Experience Required: More than 5 years

Expected Travel Time: About 25%

This company may offer relocation assistance.


Boston Scientific offers incredible opportunities to grow and advance, a dynamic work environment and an excellent benefits package. Boston Scientific is an equal opportunity employer, M/F/D/V.