Talent.com
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs SpecialistProclinical Group • Boston, MA, United States
Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Proclinical Group • Boston, MA, United States
3 days ago
Job type
  • Permanent
Job description

Senior Regulatory Affairs Specialist - Permanent - Boston MA

Can you transform regulatory challenges into opportunities that accelerate innovation in medical devices?

Proclinical is working alongside a medical device company based in the suburbs of Boston who are looking to hire a Senior Regulatory Affairs Specialist. This role has an on‑site requirement of 3‑4 days per week, so please do not apply unless this is an option for you.

Skills & Requirements

  • The ideal candidate has a solid technical background and several years of experience in regulatory affairs for medical devices.
  • They bring proven expertise in preparing global submissions, managing post‑market requirements, and navigating international regulatory frameworks.
  • They are comfortable working with complex technologies, communicating effectively across technical and commercial teams, and producing clear, well‑structured documentation.
  • Strong organizational and project management skills are essential, as is the ability to handle multiple priorities.
  • Applicants must have legal authorization to work in the United States.

The Sr Regulatory Affairs Specialist's responsibilities will be :

  • In this role, you'll lead global regulatory activities for an innovative medical device portfolio, guiding strategy, submissions, and compliance across multiple markets.
  • You'll partner closely with cross‑functional teams to support product development, ensure documentation and filings are delivered to a high standard, and maintain alignment with evolving international regulations.
  • You'll also help manage interactions with regulatory authorities, oversee post‑market requirements, and contribute to efficient processes and clear communication across the organization.
  • This position is ideal for someone who enjoys collaborating, solving complex regulatory challenges, and driving projects forward independently.
  • Compensation

  • $130,000 to $140,000 per annum.
  • If you are having difficulty in applying or if you have any questions, please contact Christian Andersen at c.andersen@proclinical.com.

    If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

    Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

    By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https : / / www.proclinical.com / privacy-policy

    #J-18808-Ljbffr

    Create a job alert for this search

    Regulatory Specialist • Boston, MA, United States

    Related jobs
    Senior Director, Regulatory Strategy Consulting

    Senior Director, Regulatory Strategy Consulting

    Halloran Consulting Group • Boston, MA, United States
    Full-time
    Career Opportunities with Halloran Consulting Group.Senior Director, Regulatory Strategy Consulting.Are you looking for a company that is committed to improving human health, and a role that will d...Show more
    Last updated: 30+ days ago • Promoted
    Senior Regulatory Affairs Director - Oncology

    Senior Regulatory Affairs Director - Oncology

    AstraZeneca • Boston, MA, United States
    Full-time
    Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on!.At AstraZeneca,...Show more
    Last updated: 8 days ago • Promoted
    Director, Regulatory Affairs - Strategy

    Director, Regulatory Affairs - Strategy

    Lantheus Brand • Bedford, MA, US
    Full-time
    Director, Regulatory Affairs - Strategy.Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering t...Show more
    Last updated: 30+ days ago • Promoted
    Regulatory Strategist

    Regulatory Strategist

    Sanofi • Cambridge, MA, US
    Full-time
    Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our...Show more
    Last updated: 30+ days ago • Promoted
    Sr. Director, Regulatory Affairs

    Sr. Director, Regulatory Affairs

    Akebia Therapeutics • Cambridge, MA, United States
    Full-time
    Nearly 37 million Americans are currently affected by Chronic Kidney Disease.At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of e...Show more
    Last updated: 30+ days ago • Promoted
    Senior Director, Global Regulatory Strategy - Hybrid+Equity

    Senior Director, Global Regulatory Strategy - Hybrid+Equity

    Alexion Pharmaceuticals, Inc. • Boston, MA, US
    Full-time
    A leading biopharmaceutical company in Boston is looking for a Senior Director, Global Regulatory Strategy to spearhead the regulatory strategy for early-stage programs. This role requires a deep un...Show more
    Last updated: 15 hours ago • Promoted • New!
    Global Regulatory Strategy Director — Rare Diseases

    Global Regulatory Strategy Director — Rare Diseases

    OSI • Boston, MA, United States
    Full-time
    A leading biotechnology company in Boston seeks a Sr.Director, Regulatory Strategist to lead global regulatory strategies and manage important regulatory submissions. Ideal candidates will have at l...Show more
    Last updated: 4 days ago • Promoted
    Director, Regulatory Affairs Strategy

    Director, Regulatory Affairs Strategy

    BlueRock Therapeutics • Cambridge, MA, United States
    Full-time
    BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases.T...Show more
    Last updated: 1 day ago • Promoted
    Global Regulatory Affairs Device Lead (Associate Director)

    Global Regulatory Affairs Device Lead (Associate Director)

    Sanofi • , MA, United States
    Full-time
    Job title • • : Global Regulatory Affairs Device Lead (Associate Director) • Serve as GRA Device Lead on assigned project teams (early phase, late stage and marketed products) • Provide regulatory guida...Show more
    Last updated: 27 days ago • Promoted
    Director, Global Regulatory Affairs - Global Labeling Strategy

    Director, Global Regulatory Affairs - Global Labeling Strategy

    Sanofi • Cambridge, MA, United States
    Full-time
    Director, Global Regulatory Affairs - Global Labeling Strategy.The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critica...Show more
    Last updated: 30+ days ago • Promoted
    Associate Director Regulatory Affairs

    Associate Director Regulatory Affairs

    Real Staffing • Boston, MA, United States
    Full-time
    Associate Director, Regulatory Affairs (Contract).Associate Director of Regulatory Affairs.This role will support regulatory strategy and execution across development programs, ensuring compliance ...Show more
    Last updated: 3 days ago • Promoted
    Regulatory Affairs Professional

    Regulatory Affairs Professional

    804 Technology • Newton, Massachusetts, US
    Full-time
    Quick Apply
    As a Regulatory Affairs Specialist Consultant, you will be responsible for : .Formulate and execute activities associated with regulatory submissions of a novel robotic medical device in the US marke...Show more
    Last updated: 16 hours ago • New!
    Director / Senior Director, Regulatory Affairs - CMC

    Director / Senior Director, Regulatory Affairs - CMC

    Vivid Resourcing • Boston, MA, United States
    Full-time
    Director / Senior Director, Regulatory Affairs - CMC (Biologics | Phase 3 Asset | Advanced Modality).Boston area (hybrid, flexible travel). A clinical-stage biotech developing an.Director / Senior Dir...Show more
    Last updated: 19 days ago • Promoted
    Regulatory Affairs Manager, CMC

    Regulatory Affairs Manager, CMC

    Vivid Resourcing • Boston, MA, United States
    Full-time
    Regulatory Affairs Manager, CMC - Biologics (Phase 3 Asset | Advanced Modality).Boston area (hybrid, flexible travel).I'm currently searching for a Regulatory Affairs professional looking to take o...Show more
    Last updated: 19 days ago • Promoted
    Associate Director, Regulatory Affairs

    Associate Director, Regulatory Affairs

    Foundation Medicine • Boston, MA, United States
    Full-time
    The Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval...Show more
    Last updated: 3 days ago • Promoted
    Senior Regulatory Affairs Specialist (IVD Exp. supporting US / Health Canada)

    Senior Regulatory Affairs Specialist (IVD Exp. supporting US / Health Canada)

    Haemonetics Software Solutions • Boston, MA, United States
    Full-time
    Haemonetics is committed to the protection of personal data in accordance with applicable laws and regulations.The editor and data controller ofwww. Haemonetics Corporation, 125 Summer Street, Bosto...Show more
    Last updated: 30+ days ago • Promoted
    Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

    Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

    Olema Oncology • Boston, MA, United States
    Full-time
    Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs at Olema Oncology.Reports to the Senior Vice President of Regulatory Affairs. Location : Boston, MA or San Francisco, CA.Domestic...Show more
    Last updated: 30+ days ago • Promoted
    Hybrid Senior Director, Global Regulatory Strategy & Early Development

    Hybrid Senior Director, Global Regulatory Strategy & Early Development

    Alexion • Boston, MA, United States
    Full-time
    A leading biopharmaceutical company in Boston is seeking a Senior Director, Global Regulatory Strategy.This role focuses on regulatory strategy for early-stage programs and requires extensive exper...Show more
    Last updated: 4 days ago • Promoted