Senior Regulatory Affairs Specialist (601547)

Additional Location(s):US-CA-Valencia; US-CA-Sunnyvale; US-MN-Arden Hills; US-MN-Maple Grove; US-MN-Minnetonka

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance

At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees tackling some of the most important health industry challenges. With access to the latest tools information and training well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About the role:

At Boston Scientific youll discover a place where you can have meaningful purpose improving lives through your lifes work. We continue to innovate in key areas and extending our products into new geographies and high-growth adjacency markets. The Senior Regulatory Affairs Specialist will be a part of the Neuromodulation Regulatory Affairs team. This individual will be responsible for planning managing and implementing regulatory submissions to the US FDA EU notified bodies as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews.

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:

• Bachelors 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

#LI-Hybrid

Requisition ID:601547

Minimum Salary: $86600

Maximum Salary: $164500

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see --will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training pertinent education including licensure and certifications among other relevant business or organizational needs. At BSC it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly) non-sales roles may 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 for exempt non-sales roles may 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.

As a leader in medical science for more than 40 years we are committed to solving the challenges that matter most united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives create value for our customers and support our employees and the communities in which we operate. Now more than ever we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.

So choosing a career with Boston Scientific (NYSE: BSX) isnt just business its personal. And if youre a natural problem-solver with the imagination determination and spirit to make a meaningful difference to people worldwide we encourage you to apply and look forward to connecting with you!

At Boston Scientific we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion equality and opportunity for all. By embracing the richness of our unique backgrounds and perspectives we create a better more rewarding place for our employees to work and reflect the patients customers and communities we serve.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy the Company will continue to take steps to assure that recruitment hiring assignment promotion compensation and all other personnel decisions are made and administered without regard to race religion color national origin citizenship sex sexual orientation gender identify gender expression veteran status age mental or physical disability genetic information or any other protected class.

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 Companys policies or protocols change with regard to COVID-19 vaccination.