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Specialist II, Reg Affairs

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
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, our products and technologies are used to diagnose or treat a wide range of medical conditions with a focus on technologies for diagnosing and treating diseases of the digestive system, airway and lungs. We have a robust product portfolio of devices currently available for sale in the European Union (EU) which require transition to approval under the new EU Medical Device Regulation (MDR).  Boston Scientific is committed to ensuring continued availability of Endoscopy devices to patients in the EU. 


This role within Regulatory Affairs will provide dedicated and on-going support of activities required to obtain timely MDR approvals for Endoscopy devices.  With guidance from the Endo regulatory affairs management team this specialist will provide technical and administrative regulatory support to the ENDO MDR project team.    


Your responsibilities include:

  • Support BSC Endo RA EU MDR project lead in implementation of MDR requirements
  • Create and submit Technical Documentation to notified bodies for review
  • Prepare Declaration of Conformity Document for signature
  • Review and signs-off on product and manufacturing changes for compliance with EU MDR regulations
  • Review and sign off design documentation for compliance with EU MDR requirements
  • Participate as regulatory core team member on product specific MDR transition teams
  • Continuously assess ways to improve Quality
  • Supports efforts to improve collaboration, experience sharing and best practices within the department and division



What we're looking for:


Required Qualifications

  • A minimum of a Bachelor’s degree in a scientific, technical, or related discipline
  • A minimum of 2 years experience in Regulatory Affairs
  • Working knowledge of current and proposed EU regulations for medical devices
  • Familiar with ISO 13485 and MDSAP requirements
  • General understanding of product development process and design control


Preferred Qualifications

  • Prior experience in the Medical industry
  • Prior experience compiling technical files or design dossiers
  • Ability to manage several projects simultaneously
  • Proficiency with Microsoft Office
  • Effective research and analytical skills
  • Effective written and oral communication, technical writing and editing skills
  • Ability to work independently with minimal supervision. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
  • Good interpersonal skills
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy


Requisition ID: 505099


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 drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), 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.


Nearest Major Market: Boston

Job Segment: Medical Device, Compliance, Regulatory Affairs, Surgery, Technical Writer, Healthcare, Legal, Technology

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