Exciting Contract to Permanent Regulatory Affairs Specialist position in greater BostonEnsures that the necessary product approvals are obtained and maintained based on planned marketsDevelops plans and procedures to achieve compliance to EU Medical Device Regulation.Liaises with Notified Bodies and/or Competent Authorities/FDA regarding regulatory and vigilance issues.Oversees, maintains and creates Quality System documentation and regulatory files.Reviews and approves validation activities.To be successful in this Regulatory Affairs Specialist role5-10 years regulatory affairs in medical device industry.Working knowledge of current FDA Quality Systems Regulation, Canadian MDR, ISO 13485 versions, Australian regulations and the EU Medical Device RegulationsHands on experience with product documentation and the preparation of 510(k)s, and international dossiers/technical filesExperience with devices containing both hardware and software components.Must have a Bachelor’s Degree in an Engineering fieldBenefits:MedicalDentalVision401KReferral bonus up to $75 Since 1984, The Reserves Network continues to partner with the finest employers to provide opportunities within the office, industrial, professional and technical markets. As a family- and veteran-owned company, we focus on candidate experience and workplace culture for the nearly 20,000 employees we place annually. For more information contact our office at If interested please send a resume to: Tracking

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