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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): 

Maple Grove, MN, US, 55311

Additional Location(s): US-MN-Arden Hills; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Plymouth

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 this role: At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. In Peripheral Intervention (PI) we treat vascular system blockages in areas such as the carotid and renal arteries and the lower extremities, treating, Peripheral Vascular Diseases and Pulmonary Embolisms.  We have a robust product line and pipeline, and we will continue to make an investment in Peripheral Interventional treatments.

 
In this role, you will be responsible for Regulatory Affairs support of global commercial products including, submissions and regulatory compliance.


Your responsibilities will include:

  • 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.
  • Assists with developing and implementing regulatory strategies for new and modified medical devices.
  • Preparation and submission of regulatory applications, as well as internal regulatory file documentation for product changes.
  • Review and approve product and manufacturing changes for compliance with applicable regulations.
  • Acts as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
  • Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation.
  • Reviews device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.
  • Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.

 

Required qualifications:

  • Minimum of a Bachelor’s degree
  • 3+ years in Regulatory Affairs or related discipline in medical devices (R&D, Quality, Clinical, Biocompatibility, Labeling)
     

Preferred qualification:

  • Excellent written and oral communication, technical writing and editing skills. Ability to translate technical information into a clearly written message for the regulators.
  • Basic submission and presentation related computer skills, including experience with software applications such as Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
  • Understanding of FDA, European and international regulations.
  • Knowledge of medical devices, procedures, and terminology.
  • Working knowledge of product development process and design controls.
  • Ability to manage multiple projects.
  • Quick learner, self-motivated, independent worker.
  • Strong technical, research and problem-solving skills.
  • Team player with excellent interpersonal skills.

 

Requisition ID: 554830


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.

 

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.


Nearest Major Market: Minneapolis

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

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