Principal Regulatory Affairs Specialist

16 hours ago

Marlborough MA United States Boston Scientific Gruppe Full time
Principal Regulatory Affairs Specialist - Endoscopy

Onsite Location(s): Marlborough, MA, US, 01752

Additional Locations: 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 Endoscopy division, we provide advance technologies for diagnosing and treating diseases of the digestive system, airway and lungs. We have a robust product line and pipeline, and we will continue to make an investment in Endoscopy treatments. This role in Regulatory Affairs will be responsible for 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.

Your responsibilities include:

  1. Under minimal supervision, 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.
  2. Assists with developing and implementing regulatory strategies for new and modified medical devices, as well as for OEM and Contract Manufacturer partnerships.
  3. Is a liaison for new business partners to provide regulatory guidance for US, EU, China, and International product registration.
  4. Acts as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
  5. Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation.
  6. Reviews device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.
  7. Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
  8. Support and maintain Quality initiatives in accordance with BSC Quality Policy.
  9. Continuously assess ways to improve Quality.

What we're looking for in you:

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 with 510K submissions
  4. Prior experience with Class III devices
  5. Prior experience with EU MDR.
  6. Prior experience with China and international regulatory requirements.
  7. Working knowledge of FDA and international regulations for medical devices.
  8. General understanding of product development process and design control.
  9. General understanding of regulations applicable to the conduct of clinical trials.

Preferred qualifications:

  1. Fluent in Mandarin
  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.

Requisition ID: 588701

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

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