Principal Regulatory Affairs Specialist

1 month ago

Arden Hills, Minnesota, United States Boston Scientific Full time

Recruiter: Spencer Gregory Hale

Principal Regulatory Affairs Specialist

About the role:
The Regulatory Associate is responsible for activities which lead, improve and drive efficiencies across regulatory product approval processes. Acts as a primary Regulatory Affairs representative in Material Controls, Supplier Quality and Medical Electrical Equipment spaces. Additionally, the Associate is responsible for representing regulatory interests within quality system projects and process changes, process ownership and audit support.

Your responsibilities will include:

  • Perform as the Regulatory Affairs Lead team member on initiatives to transform how we address the unique needs of capital equipment life cycle within the quality system (from part creation, labeling and testing to distribution and servicing).
  • Collaborate with cross functional partners (specifically Supplier Quality, Material Controls and Design Controls) as the Voice of Regulatory to deliver innovative solutions for achieving and maintaining compliance in the areas of Medical Electrical Equipment, Material Controls, Supplier Quality, and others.
  • Proactively influence global site and divisional partners and leadership in interpretation/understanding of new concepts and requirements and adoption of Best Practices. In addition, working to ensure understanding and translation of strategies, goals and the full scope of Business Transformation initiatives.
  • Partner with cross divisional team members and business unit and country regulatory affairs to identify process gaps and opportunities for process efficiencies.
  • Identify, establish business cases for, initiate and lead projects to address needs within the medical equipment space.
  • Actively participate in various Quality System Community of Practice teams representing Regulatory Affairs interests, assessing impact, and bringing awareness to Regulatory Teams.
  • Actively participate in advocacy streams to get a pulse on regulation trends and expectation as well as benchmark against other industry leaders (current areas for connection include repair, cybersecurity, and others).
  • Author, revise and edit standard operating procedures and work instructions.
  • Participate as the Regulatory Affairs SME in assessments for global requirement changes and collaborate with cross-functional partners to influence changes to the quality system as needed.
  • Coordinate regulatory strategy and execute on deliverables to allow for implementation of manufacturing process changes impacting multiple divisions.
  • Participate in training and mentoring of staff.
  • Participate in department systems development initiatives.

Required qualifications:

  • Minimum of a Bachelor's degree
  • Minimum of 5 years' experience in Regulatory Affairs or a related discipline (e.g. Quality Systems, R&D, Quality, Post Market) within the medical device, IVD, pharmaceutical or healthcare industries
  • Working knowledge of FDA, EU and/or international medical device regulations
  • Experience with audits from regulatory bodies (e.g. MDSAP and ISO 13485)
  • Ability to read and interpret global regulations and standards
  • General understanding of product development process, design controls and quality system regulations
  • Proficiency with Microsoft Office applications (Teams, Word, Excel, PowerPoint)

Preferred qualifications:

  • Degree or work experience in a scientific or technical discipline
  • Experience of managing complex matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization.
  • Excellent written and oral communication, technical writing and editing skills
  • Excellent research and analytical skills
  • Ability to manage multiple projects simultaneously
  • High sense of urgency and commitment to execution.
  • Proven leadership, collaboration and influencing skills
  • Willingness to travel to divisions, regions, and corporate headquarters (estimate 10% travel in non-pandemic conditions)

Requisition ID:588395

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.



Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

  • Senior Regulatory Affairs Consultant

    1 week ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Recruiter: Spencer Gregory HalePosition: Principal Regulatory Affairs SpecialistOverview:The Principal Regulatory Affairs Specialist plays a pivotal role in enhancing and streamlining regulatory product approval workflows. This position serves as a key representative for Regulatory Affairs within the realms of Material Controls, Supplier Quality, and Medical...

  • Senior Regulatory Affairs Consultant

    1 week ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Recruiter: Spencer Gregory HalePosition Overview:The Principal Regulatory Affairs Specialist plays a crucial role in enhancing and streamlining regulatory product approval workflows. This position serves as a key Regulatory Affairs representative within the domains of Material Controls, Supplier Quality, and Medical Electrical Equipment.Moreover, the...

  • Senior Regulatory Affairs Consultant

    1 week ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Recruiter: Spencer Gregory HalePosition Overview:The Principal Regulatory Affairs Specialist plays a crucial role in enhancing and streamlining regulatory product approval processes. This position serves as a key representative in the domains of Material Controls, Supplier Quality, and Medical Electrical Equipment.Moreover, the Specialist is tasked with...

  • Sr. Regulatory Specialist

    4 weeks ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Recruiter: Spencer Gregory HaleSr. Regulatory Specialist - Electrophysiology Pulsed Field AblationAt Boston Scientific, you'll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and protecting against sudden...

  • Reg Affairs Specialist II

    1 month ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Recruiter: Spencer Gregory HaleReg Affairs Specialist II - CRMYou'll discover a place where you can have meaningful purpose, improving lives through your life's work. 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...

  • Scientific Affairs Principal,Rhythm Management-

    1 month ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Additional Location(s):US-MN-Northern/Duluth; US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-PlymouthDiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of...

  • Principal Sourcing Specialist

    1 month ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Additional Location(s): N/A; US-MN-Arden HillsDiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt 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...

  • Principal Compliance Analyst

    1 month ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt 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,...

  • Principal Compliance Analyst

    1 month ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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...

  • Principal Skills Training Specialist

    1 month ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Additional Location(s):US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Northern/Duluth; US-MN-PlymouthDiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of...

  • DE&I Talent Management Principal Specialist

    1 month ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Additional Location(s):US-MN-Arden Hills; Canada-ON-Ottawa; Costa Rica-Heredia; Ireland-Galway; Puerto Rico-Dorado; US-MA-MarlboroughDiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing...

  • Principal Learning

    1 month ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Additional Location(s):US-MN-Arden Hills; Costa Rica-Heredia; Ireland-Cork; Ireland-Galway; Puerto Rico-Dorado; US-MA-MarlboroughDiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing...

  • Principal HEOR Economist

    3 weeks ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Additional Location(s): US-MN-Arden Hills; US-MA-MarlboroughDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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...

  • Senior Quality Complaint Specialist

    1 week ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Recruiter: Spencer Gregory Hale Senior Quality Complaint SpecialistAbout the role: This position offers specialized technical, reporting, and analytical support in the evaluation of product quality complaints, acting as the primary liaison. The role involves monitoring complaint data and providing expert guidance to enhance complaint analysis methodologies...

  • Principal Cybersecurity Engineer

    4 weeks ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Additional Location(s):US-MA-MarlboroughDiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt 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...

  • Labeling & Registration Specialist

    2 months ago

    Arden Hills, Minnesota, United States LandOLakes Full time

    Labeling & Registration SpecialistThe main responsibilities are to coordinate with internal and external partners to execute the project management of artwork for containers and cartons for proprietary products; Liase between Marketing, Sourcing, Federal Registration, label and carton vendors and for internal and external companies. Help with state...

  • Global Capital Equipment Senior Operations Manager

    3 weeks ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt 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,...

  • Senior Sales Training Specialist, Electrophysiology

    2 weeks ago

    Arden Hills, Minnesota, United States Boston Scientific Gruppe Full time

    Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceBei Boston Scientific bieten wir Ihnen die Möglichkeit, all Ihre Fähigkeiten zu entfalten, indem Sie in Teams von vielfältigen und leistungsstarken Mitarbeitern arbeiten, die einige der wichtigsten Herausforderungen der Gesundheitsbranche angehen. Mit Zugang zu den...

  • Director of Field Sales Development

    4 weeks ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Additional Location(s): N/A; RemoteDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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...

  • Senior Quality Manager

    1 month ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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...