Boston Scientific Senior Regulatory Affairs Specialist 

United States, California, Santa Clarita 

749034761

About the role:

This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Valencia, CA (preferred), Sunnyvale, CA, or Arden Hills, Maple Grove or Minnetonka, MN. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Your responsibilities will include:

• Acts as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submissions strategy/regulatory pathway development testing requirements, clarification and follow-up of submissions under review
• Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR
• Supports and implements the development of domestic and international strategies for Class II and III medical devices for new and modified medical devices
• Assists with departmental policy and procedure implementation
• Assists with Regulatory Affairs training to cross functional groups
• Represent RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
• Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations
• Reviews device labeling and advertising materials for compliance with global submissions and applicable regulations; analyzes and recommends appropriate changes
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations
• Support international geographies to gain and maintain product approvals
• Support efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing
• Supporting regulatory audits, as required

Required qualifications:

• Bachelor’s degree, minimum
• 4+ years Regulatory Affairs or related discipline in medical devices (R&D, Quality, Clinical, Biocompatibility, Labeling, etc.)
• Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as various US PMA supplements, 510(k)s and EU MDR technical documentation
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Preferred qualifications:

• Previous experience in the medical device industry with Class II or III device submissions
• General understanding of product development process and design controls
• Working knowledge of FDA, EU and international regulations
• Ability to manage several projects
• Effective research and analytical skills
• Effective written and oral communication, technical writing and editing skills
• Works well in fast-paced cross-functional team environments
• Team player with excellent interpersonal skills

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.