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Specialist II, Peripheral Interventions, Reg Affairs Job

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Date: May 11, 2021

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

Additional Locations: (n/a)

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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:

Responsible for Regulatory Affairs support, submissions, and regulatory compliance on the Peripheral Interventions Regulatory Affairs Team.

 

Key Responsibilities:

  • Acts as a core member on manufacturing and development teams, providing Regulatory Affairs feedback and guidance throughout the product lifecycle.
  • Reviews and approves product and manufacturing changes for compliance with applicable regulations.
  • Responsible for preparation and submission of regulatory applications and internal regulatory documentation related to 510(k)s, Design Dossiers/Technical Files, and MDR Technical Documentation.
  • Provides information to International Regulatory Affairs groups to support the submission activities in various countries.
  • Converts MDD files to EU MDR 2017/745 regulatory requirements.
  • Provides updates on regulatory requirement changes, either on individual product specifications or quality systems.
  • Supports the QA function during external agency audits.

 

What we’re looking for:

Minimum qualifications:

  • 2 years of experience in regulatory affairs
  • Specific experience in strategic planning, preparation, and submission of 510(k)s, Technical Files, and Design Dossiers
  • Experience in EU MDD, EU MDR, FDA, and ISO environments
  • Strong team member with the ability to identify and drive regulatory compliance improvements
  • Good administrative/organizational ability with excellent attention to detail
  • Excellent technical writing skills
  • Excellent communication skills
  • Excellent analytical/decision making skills

 

Preferred qualifications:

  • Medical Device experience

Requisition ID: 478736

 

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: Minneapolis

Job Segment: Medical, Law, Compliance, Strategic Planning, Healthcare, Legal, Quality, Strategy