Regulatory Affairs Specialist III

1 week ago

Osseo, Minnesota, 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 this role:
This role will support Franchise goals of the Interventional Cardiology Calcium Management Regulatory Affairs (RA) team (rotational atherectomy).

This role is responsible for the coordination and preparation of document packages for regulatory submissions in one or more of the following geographic regions:
United States, Europe, Japan, Canada, and Intercontinental.

Your responsibilities will include:

  • Under direct supervision of the RA Project Manager, or Department Manager, assists in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, IDES, IDE Progress Report, Clinical Trial Submission [OUS], 510(k), PMA, PMA Annual Report, Shonin, PLA, CE-Mark Design Dossier, CE-Mark Technical File, Intercontinental Dossiers, Certificates to Foreign Government. Ensures that existing approvals and documentation are maintained, including SAP Foreign Trade Status. Communicates with in-country RA personnel to facilitate global clearances/approvals.
  • Under the direct supervision of RA Project Manager or RA Department Manager, develops global regulatory strategies for project teams.
Provides input on and reviews protocols and reports for:
design verification, design validation, shelf life, pre-clinical, etc.

  • Communicates with regulatory agencies under direct supervision of the RA Project Manager or RA Department Manager.
  • Evaluates proposed changes to products and controlled documents; recommends and implements global regulatory action plans based on the changes. Organizes and maintains RA files.
  • Reviews labeling (Instructions for Use, labels, promotional materials) for compliance to standards, guidelines, regulations, and regulatory approvals/clearances.
  • Assists in performing basic to moderately complex research to support strategic planning.
  • May mentor others on an infrequent basis. Is not expected to supervise others.
  • Provides regulatory support to other Boston Scientific Personnel to facilitate cross-divisional leverage.
  • Analyzes existing systems and procedures, recommends solutions/improvements, and writes Work Instructions, SOPs, and SLPs as needed to support departmental functions and Target's Quality System.
  • Understands: Boston Scientific's systems, biocompatibility requirements, Design Control, Medical Device Directive, Essential Requirements, ISO 46000 series, labeling requirements, Quality System Regulation, export requirements, and regulatory requirements
  • Uses existing project management tools.
  • Performs responsibilities required by the Quality System and other duties as assigned or requested.

Required qualifications:

  • University degree or the equivalent combination of education and experience required; advanced/graduate degree preferred for some disciplines
  • 2-4 years of experience

Preferred qualifications:

  • Experience working with Interventional Cardiology products
  • Experience working with medical devices subject to electrical and mechanical safety standards (IEC
Requisition ID: 584451


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 prohibited substance free workplace. Pursuant to Va.

Code § , 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:
Regulatory Affairs, Compliance, Medical Device, Strategic Planning, Clinical Research, Legal, Healthcare, Strategy

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