Principal Regulatory Affairs Specialist

1 day ago

Marlborough MA 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, this is a place where you can find meaningful purpose, improving lives through your life's work. In the Urology division, we continually advance the quality of patient care with innovative urology solutions. This role will be responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process, as well as developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion.


This is a hybrid role (in office 3 days per week) based in Marlborough, MA.


Your responsibilities will include:


  1. Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
  2. Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
  3. Assists with developing and implementing regulatory strategies for new and modified medical devices, as well as for OEM and Contract Manufacturer partnerships.
  4. Is a liaison for new business partners to provide regulatory guidance for US, EU, China, and international product registration.
  5. Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
  6. Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
  7. Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes.
  8. Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
  9. Support and maintain Quality initiatives in accordance with BSC Quality Policy.
  10. Continuously assess ways to improve Quality.
  11. Develops and implements departmental and divisional policies and procedures.
  12. Supports highly technical or major business segment product lines, special projects or strategic initiatives.

Required Qualifications:


  1. A minimum of a Bachelor's Degree in a scientific, technical, or related discipline.
  2. A minimum of 8 years Regulatory Affairs experience in the medical industry.
  3. Prior experience of supporting both the capital equipment as well as single-use disposables.
  4. Prior experience with 510(k) submissions, EU MDR and international regulatory registrations.
  5. Working knowledge of FDA, EU and international regulations for medical devices.
  6. Ability to read and interpret global regulations and standards.
  7. General understanding of product development process, design control and quality system regulations.
  8. General understanding of regulations applicable to the conduct of clinical trials.

Preferred Qualifications:


  1. Prior experience supporting contract manufactured and/or OEM products.
  2. Ability to simultaneously manage several projects.
  3. Proficiency with Microsoft Office.
  4. Effective research and analytical skills.
  5. Effective written and oral communication, technical writing and editing skills.
  6. Ability to work independently with minimal supervision.

#LI-Hybrid


Requisition ID: 593123


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.


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.

#J-18808-Ljbffr

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