Regulatory Affairs Specialist

3 days ago


Reston, Virginia, United States Cypress HCM Full time

Job Title: Senior Regulatory Affairs Specialist

Location: Cypress HCM

Experience: Must have experience composing submissions for IVD devices

Position Overview:

The Senior Regulatory Affairs Specialist will coordinate the collection of technical information and prepare regulatory submissions for in vitro diagnostic (IVD) and medical device licenses for various governmental agencies. Additionally, they will coordinate clinical study trials, including offsite locations when necessary.

Key Responsibilities:

  • Coordinate submission and review of documents for inclusion in Design History Files.
  • Draft, edit, and compile technical documentation and design dossiers to support CE mark/UKCA mark regulatory filings.
  • Prepare post-market product surveillance reports.
  • Prepare EU/UK vigilance reports as needed.
  • Prepare regulatory submissions for FDA 510(k) clearance and A2F submissions.
  • Assist in the registration and application process for Class II & III Medical Device Licenses in Health Canada.
  • Research regulatory requirements from FDA, CMDR, MDR, IVDR, and UK MDR2002 guidance documents.
  • Review labeling, package inserts, advertising materials, and company website content to ensure compliance with FDA and CE regulatory requirements.
  • Maintain and update regulatory documentation and track submissions.
  • Ensure compliance with Essential Requirements Checklists and applicable standards as revisions are introduced.
  • Provide technical documentation to Competent Authorities and Notified Bodies.
  • Assist OEM customers in obtaining CE marks for their products.

Education & Experience:

  • Bachelor's degree in a related field or equivalent experience.
  • Minimum of 6-7 years of experience, with at least 3 years of experience in preparing and submitting 510(k) or CE technical files for IVD devices.

Required Skills & Abilities:

  • Strong working knowledge of medical device regulations and terminology.
  • Excellent written and oral communication skills, including technical writing and editing.
  • Ability to produce clear, concise technical documentation.
  • Skilled in analyzing and summarizing data.
  • Proficient with Microsoft Office.
  • Ability to manage and prioritize multiple projects in a fast-paced environment.
  • High attention to detail and accuracy in following written and verbal directions.
  • Ability to work collaboratively in a team setting.
  • Knowledge of QSRs, ISO 13485, IVDD/IVDR, MDD/MDR, UK MDR 2002, CMDR, GMP, and 21 CFR.

$115k-$127k



  • Reston, Virginia, United States Meet Full time

    Regulatory Affairs SpecialistLocation: Our innovative client is seeking a Regulatory Affairs Specialist to support regulatory submissions and ensure global compliance with regulatory standards. This role is crucial in managing and preparing documentation for product lifecycle management and licensing activities.Key Responsibilities:Prepare and coordinate...


  • Reston, Virginia, United States Synerfac Technical Staffing Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs and Documentation Specialist to join our team at Synerfac Technical Staffing. The ideal candidate will have 1-3 years of experience in Regulatory Affairs in the medical device space and be knowledgeable with international regulations.Key Responsibilities• Prepares documentation for international...


  • Reston, Virginia, United States Tucker Parker Smith Group (TPS Group) Full time

    {"Job Title": "Regulatory Affairs Specialist", "Job Summary": "We are seeking a highly skilled Regulatory Affairs Specialist to support our client\u2019s transition to the EU\u2019s In Vitro Diagnostic Regulation (IVDR).", "Responsibilities": "\u2022 Support the IVDR project by revising technical files and attending weekly meetings to address issues and...


  • Reston, Virginia, United States Wondercide Full time

    Regulatory Affairs SpecialistWondercide is seeking a highly skilled Regulatory Affairs Specialist to join our innovation team. As a key member of our regulatory compliance team, you will be responsible for managing all regulatory submissions and ensuring accurate, consistent compliance with regulations in packaging and marketing.Key Responsibilities:Develop...


  • Reston, Virginia, United States Bayside Solutions Full time

    Regulatory Affairs SpecialistW2 ContractSalary Range: $41,600 - $52,000 per yearLocation: South San Francisco, CA - Hybrid RoleJob Summary:As a key member of our Regulatory Affairs team, you will play a critical role in ensuring compliance with FDA regulations and guidelines. You will be responsible for organizing and identifying gaps in Regulatory files and...


  • Reston, Virginia, United States NeuroVasc Technologies, Inc. Full time

    Senior Regulatory Affairs SpecialistWe are NeuroVasc Technologies, a company that delivers excellence through innovation with integrity.This role is on-site and reports directly to the CEO. The Senior Regulatory Specialist is responsible for planning, directing, and coordinating global product registrations and leading regulatory submissions planning and...


  • Reston, Virginia, United States NeuroVasc Technologies, Inc. Full time

    Senior Regulatory Affairs SpecialistWe are NeuroVasc Technologies, a company that delivers excellence through innovation with integrity.This role is on-site and reports directly to the CEO. The Senior Regulatory Specialist is responsible for planning, directing, and coordinating global product registrations and leading regulatory submissions planning and...


  • Reston, Virginia, United States Accordance Search Group Full time

    Job SummaryWe are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at Accordance Search Group.This is a challenging and rewarding role that requires a strong understanding of regulatory requirements and a proven track record of success in ensuring compliance.Key ResponsibilitiesDevelop and implement regulatory strategies to...


  • Reston, Virginia, United States Tucker Parker Smith Group (TPS Group) Full time

    Regulatory Affairs Specialist OpportunityJoin our team at Tucker Parker Smith Group (TPS Group) as a Regulatory Affairs Specialist II in Irvine, CA. This 12-month assignment offers a competitive pay rate of $45-$49/hr.Job Responsibilities:Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities by revising technical files, ensuring...


  • Reston, Virginia, United States Accordance Search Group Full time

    Job SummaryWe are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at Accordance Search Group.This is a challenging and rewarding role that requires a strong understanding of regulatory requirements and a proven track record of success in ensuring compliance.Key ResponsibilitiesDevelop and implement regulatory strategies to...


  • Reston, Virginia, United States GForce Life Sciences Full time

    Job Overview:GForce Life Sciences is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with local regulations, particularly in the US and Canada.Key Responsibilities:Review and analyze formulas for compliance with local regulations, focusing on US...


  • Reston, Virginia, United States Discover International Full time

    Principal Regulatory SpecialistDiscover International is seeking a highly skilled Principal Regulatory Specialist to join our growing team working on novel technology in the Neurological/Spine space. This role is based in the San Francisco Bay Area, offering a unique chance to make a significant impact in the medical device industry.Key...


  • Reston, Virginia, United States Proclinical Staffing Full time

    Associate Director, Regulatory AffairsProclinical Staffing is seeking an experienced Associate Director, Regulatory Affairs to join a clinical-stage biopharmaceutical company in the San Francisco Bay Area.Key Responsibilities:Develop and implement regulatory strategies for development programs in rare diseases.Collaborate with cross-functional teams to...


  • Reston, Virginia, United States Proclinical Staffing Full time

    Regulatory Affairs Director OpportunityProclinical Staffing is seeking a seasoned Regulatory Affairs Director to join a clinical-stage biopharmaceutical company in the San Francisco Bay Area.Key Responsibilities:Develop and implement regulatory strategies for development programs in rare diseases.Collaborate with cross-functional teams to ensure timely...


  • Reston, Virginia, United States EPM Scientific Full time

    {"title": "Regulatory Affairs Manager", "summary": "EPM Scientific is seeking a highly skilled Regulatory Affairs Manager to support the development and submission of regulatory documents for a leading pharmaceutical client. The successful candidate will have extensive experience in regulatory affairs, with a strong understanding of FDA guidelines and...


  • Reston, Virginia, United States Proclinical Staffing Full time

    Lead Regulatory Affairs for a Biotech PortfolioProclinical Staffing is seeking a seasoned Regulatory Affairs professional to lead strategic regulatory decisions for an innovative biotech portfolio.Key Responsibilities:Develop and implement global regulatory strategies for the biotech portfolio.Oversee and mentor a growing regulatory team.Ensure compliance...


  • Reston, Virginia, United States Barrington James Full time

    Senior Regulatory Associate - Hybrid RoleBarrington James is partnering with a global commercial pharmaceutical company to find a talented Senior Regulatory Associate to join their team. This is a hybrid role based in New Jersey, offering a great opportunity to work on diverse projects.In this role, you will be the Regulatory lead for submission planning and...


  • Reston, Virginia, United States LanceSoft, Inc. Full time

    Job Title: Regulatory Affairs ManagerLanceSoft, Inc. is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to meet business objectives.Responsibilities:Prepare and submit regulatory...


  • Reston, Virginia, United States Wellington Executive Search Full time

    Job Title: Regulatory Affairs ManagerJob Summary:We are seeking a highly skilled Regulatory Affairs Manager to join our team at Wellington Executive Search. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and maintaining a strong reputation in the industry.Key Responsibilities:Collaborate with...


  • Reston, Virginia, United States Proclinical Staffing Full time

    Regulatory Affairs ManagerProclinical Staffing is seeking a seasoned Regulatory Affairs Manager to join our team in the San Francisco Bay Area. As a key member of our global regulatory team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with global medical device regulations.Key Responsibilities:Develop...