Senior Regulatory Affairs Specialist

Boston Scientific

  • Arden Hills, MN
  • $82,600 per year
  • Permanent
  • Full-time
  • 7 days ago
Additional Location(s): US-MN-Arden Hills; N/A; US-MA-CambridgeDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s 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, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.At Boston Scientific, you’ll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and protecting against sudden cardiac arrest. We continue to innovate in key areas and extending our products into new geographies and high-growth adjacency markets.About this role:
The Senior Regulatory Specialist is responsible for planning, authoring, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product approvals and registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact assessment and approvals.This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills, MN or Waltham, MA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.Your responsibilities will include:
  • Develop global strategies for regulatory approval of all medical device classifications
  • Coordinate, author, compile, and submit U.S. and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, CE Mark submissions under MDR and US clinical investigation submissions
  • Support requests from BSC International Regulatory personnel related to submissions, registrations, and change assessments and from clinical personnel related to international clinical investigation submissions
  • Develop and maintain positive relationships with regulatory body reviewers
  • Review Technical and Labeling documentation for inclusion in regulatory filings or as part of design changes
  • Review product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
  • Represent RA on cross functional projects which may include product development, sustaining changes, and continuous improvement efforts
  • Support regulatory audits, as required
  • In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures
Required Qualifications:
  • A minimum of a Bachelor's Degree
  • A minimum of 4 years of regulatory affairs or related experience
  • Demonstrated experience authoring a variety of regulatory submissions for US and EU
  • Basic submission and presentation related computer skills, including experience with Microsoft Word, Excel, PowerPoint and Adobe Acrobat
Preferred Qualifications:
  • Previous experience in the medical device industry with Class II or III device submissions
  • Experience working directly with FDA, notified bodies and/or international health authorities
  • Experience working with capital equipment or software devices
  • Strong technical, research and problem-solving skills
  • Ability to articulate complex ideas clearly both verbally and in writing
  • Team player with excellent interpersonal and communication skills
  • Demonstrated ability to effectively manage multiple projects and priorities
  • Works well in fast-paced cross-functional team environments
#LI-HybridRequisition ID: 612418Minimum Salary: $82600Maximum Salary: $156900The 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) isn’t just business, it’s personal. And if you’re 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 Company’s policies or protocols change with regard to COVID-19 vaccination.

Boston Scientific