Principal Reg Affairs Specialist

Found in: Talent US C2 - 2 weeks ago

Arden Hills, United States Boston Scientific Full time

About the role:

At 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 cardiac arrest. We continue to innovate in key areas and extending our products into new geographies and high-growth adjacency markets.

This role will be responsible for working on Boston Scientific’s novel Atrial Fibrillation technology, the FARAPULSE Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System was the first PFA technology that received a CE Mark in Europe and recently received PMA approval in the US. PFA technology has the potential to alter the future of ablation therapy on a global scale as we expand the reach of this product into other geographies and with different indications.

Under minimal supervision, the Principal Regulatory Affairs Specialist is responsible for developing regulatory strategy, planning, managing, and implementing regulatory approvals in the US and EU, as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals.

Your responsibilities will include:

Develops domestic and international strategies for regulatory approval of Class I, II and III medical devices Researches and advises company on country specific international product registration and compliance related requirements Coordinates, compiles, and submits U.S. and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR Supports international regulatory partners with investigational device and commercial marketing applications Develops and maintains positive relationships with regulatory agency staff Technical and labeling reviews of supporting documents for inclusion in regulatory filings Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings Represents RA on cross functional projects which may include product development, manufacturing process changes, site transfers, and continuous improvement efforts Review of clinical study protocols and other clinical documentation, and assessment of clinical study related changes to determine the regulatory impact Review and approval of marketing materials Lead and/or participate in regulatory audits, as required

What we’re looking for in you:

Required qualifications:

A minimum of a Bachelor's Degree A minimum of 8 years of regulatory affairs or related experience, or 5 years’ experience with an advanced degree (Masters or PhD) Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations Able to work independently with minimal supervision Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control Demonstrated leadership, strategic thinking, project planning, and project management skills Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s and CE Design Dossiers, Tech Files, and MDR Tech Docs Strong technical, research and problem-solving skills Able to work well in fast-paced cross-functional team environments Ability to articulate complex ideas clearly both verbally and in writing Demonstrated ability to develop strong relationships with regulatory agency staff Demonstrated ability to effectively lead multiple regulatory projects and priorities Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Preferred qualifications:

Bachelor's Degree in life sciences, engineering, or related field Previous experience in the medical device industry with Class II or III device submissions Experience working directly with FDA, notified bodies and/or international health authorities Prior experience with electrophysiology and/or medical electronic equipment products

Requisition ID:  581430

Among other requirements, Boston Scientific maintains specific prohibited substance test 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.

  • Principal Reg Affairs Specialist

    Found in: beBee S US - 1 week ago

    Arden Hills, United States Boston Scientific Full time

      Principal Regulatory Affairs   About the role: At Boston Scientific, you’ll discover a place where you can find meaningful purpose, improving lives through your life's work. The Global Regulatory Affairs Operations team is looking for a dynamic, well-organized individual who can be a contributing member of a global work environment. This...

  • Principal Reg Affairs Specialist

    Found in: beBee jobs US - 2 weeks ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    Principal Regulatory Affairs About the role: At Boston Scientific, you'll discover a place where you can find meaningful purpose, improving lives through your life's work. The Global Regulatory Affairs Operations team is looking for a dynamic, well-organized individual who can be a contributing member of a global work environment. This individual will report...

  • Regulatory Affairs Manager

    Found in: Talent US C2 - 1 week ago

    Arden Hills, United States Boston Scientific Full time

    Recruiter: Spencer Gregory Hale Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC Team Purpose: The Rhythm Management (RM) Regulatory Affairs leadership team is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions for customers throughout the product lifecycle. This role is...

  • Principal Regulatory Affairs Specialist

    Found in: beBee jobs US - 2 hours ago

    Arden Hills, Minnesota, United States Boston Scientific Full time

    About the role:At Boston Scientific, you'll discover a place where you can find meaningful purpose, improving lives through your life's work. The Global Regulatory Affairs Operations team is looking for a dynamic, well-organized individual who can be a contributing member of a global work environment. This individual will report into the Manager responsible...

  • Regulatory Specialist II

    22 hours ago

    Arden Hills, United States Boston Scientific Full time

    Recruiter: Spencer Gregory Hale Regulatory Specialist II, Electrophysiology Pulsed Field Ablation, Regulatory Affairs At 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...

  • Regulatory Affairs Specialist

    1 week ago

    Laguna Hills, United States Insight Global Full time

    Support and prepare documentation for regulatory submissions and registrations (FDA and EU regulatory entities) IDE, PMA, 510 (k), Design Dossiers, Technical Files. Maintain regulatory Technical Files Review changes to Existing Products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements...

  • Regulatory Affairs Specialist

    2 weeks ago

    Short Hills, United States Katalyst HealthCares & Life Sciences Full time

    Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers Experience in reviewing of quality documents such as Reformulation studies, process validations, particle size method...

  • HR / Administrative Specialist

    3 weeks ago

    Farmington Hills, United States Cinter Career Full time

    Job DescriptionJob DescriptionWe are seeking a HR/ Administrative Specialist in Farmington Hills, MIClient: Japanese Automotive (Tier 2)General Position SummaryThe HR /Administrative Specialist is responsible for supporting various HR and General Affairs administrative activities and will run the daily functions of the HR department including hiring,...

  • Associate Director, Medical Strategy

    Found in: Talent US C2 - 3 days ago

    Parsippany-Troy Hills, United States OPEN Health Full time

    Associate Director, Medical Strategy Reports to SVP, Medical StrategyJob SummaryThe Associate Director, Medical Strategy is responsible for providing strategic medical and tactical direction to support all of OPEN Health’s Scientific Communications teams in (1) the development of strategic medical plans and multi-stakeholder scientific communication plans,...

  • Compliance Manager, Wealth

    1 week ago

    Farmington Hills, United States Comerica Full time

    Senior Compliance Manager - Wealth and Trust Compliance Advisory ManagerThe Wealth and Trust Compliance Advisory Manager within the second line of defense is responsible for planning, developing, and managing a comprehensive compliance management program for the Wealth Management division of Comerica including Private Banking, Trust Services, and...

  • Guidance Counselor/Intake Coordinator

    Found in: Talent US C2 - 1 week ago

    Dix Hills, United States SCO Family of Services Full time

    Job Details Description PURPOSE OF THE POSITION: To monitor academic progress of students, offer intervention when services are needed, and actively prepare a transition plan for student discharges. To support the intake process for students in the Day School Program. REPORTS TO: Principal SUPERVISES: N/A I. SPECIFIC RESPONSIBILITIES: ...

  • Medical Writer, Medical Communications

    1 week ago

    Parsippany-Troy Hills, United States OPEN Health Full time

    Medical Writer/Senior Medical Writer, Medical CommunicationsApproved for FT remote in the United StatesOur Medical Writer/Senior Medical Writers work as part of a multidisciplinary team (including medical director, editor, graphic designers, and account personnel) to produce slide presentations, meeting summaries, web-based and social media materials,...