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Principal Regulatory Affairs Specialist

4 months ago

Arden Hills, Minnesota, United States Boston Scientific Full time

Additional Location(s): N/A

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

At 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.

About the role:

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.

This role will be responsible for working on Boston Scientific's novel Atrial Fibrillation technology, the FARAPULSE Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System was the first PFA technology that received a CE Mark in Europe and recently received PMA approval in the US. PFA technology has the potential to alter the future of ablation therapy on a global scale as we expand the reach of this product into other geographies and with different indications.

Your responsibilities will include:

  • Develops domestic and international strategies for regulatory approval of Class I, II and III medical devices
  • Researches and advises company on country specific international product registration and compliance related requirements
  • Coordinates, compiles, and submits U.S. and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR
  • Supports international regulatory partners with investigational device and commercial marketing applications
  • Develops and maintains positive relationships with regulatory agency staff
  • Technical and labeling reviews of supporting documents for inclusion in regulatory filings
  • Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
  • Represents RA on cross functional projects which may include product development, manufacturing process changes, site transfers, and continuous improvement efforts
  • Review of clinical study protocols and other clinical documentation, and assessment of clinical study related changes to determine the regulatory impact
  • Review and approval of marketing materials
  • Lead and/or participate in regulatory audits, as required

Required qualifications:

  • Minimum of a bachelor's degree
  • Minimum of 8 years of regulatory affairs or related experience, or 5 years' experience with an advanced degree (Masters or PhD)
  • Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
  • Able to work independently with minimal supervision
  • Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control
  • Demonstrated leadership, strategic thinking, project planning, and project management skills
  • Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s and CE Design Dossiers, Tech Files, and MDR Tech Docs
  • Strong technical, research and problem-solving skills
  • Able to work well in fast-paced cross-functional team environments
  • Ability to articulate complex ideas clearly both verbally and in writing
  • Demonstrated ability to develop strong relationships with regulatory agency staff
  • Demonstrated ability to effectively lead multiple regulatory projects and priorities
  • Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Preferred qualifications:

  • Bachelor's Degree in life sciences, engineering, or related field
  • 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
  • Prior experience with electrophysiology and/or medical electronic equipment products

Requisition ID:581430

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 is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a prohibited substance freeworkplace. Pursuant to Va. Code * , Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

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 is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran