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    Regulatory Affairs Specialist (Medical Device)

    Katalyst Healthcares & Life Sciences
    2+ years
    Not Disclosed
    Boston
    10 Nov. 11, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Medical Device Regulatory Affairs Specialist (STED File Development)

    Location: Remote
    Employment Type: Contract

    Company Overview:

    Katalyst Healthcares & Life Sciences is currently hiring entry-level candidates for several contract research positions in clinical trials for drugs, biologics, and medical devices. We collaborate with university hospitals, pharmaceutical companies, and recruiting partners to advance cutting-edge therapies.

    Position Overview:

    We are seeking an experienced Medical Device Regulatory Affairs Specialist to assist in the creation of STED (Summary Technical Documentation) files for legacy medical devices. The individual in this role will focus on reviewing legacy technical files for compliance with the Medical Device Directive (MDD) 93/42/EEC (amended by 2007/47/EC) and identifying any gaps related to product labeling, clinical evaluation, and other regulatory requirements. This role will involve close collaboration with cross-functional teams, including R&D, Quality, and Regulatory, to ensure compliance and regulatory readiness.

    Key Responsibilities:

    • STED File Creation: Construct a draft STED file using legacy medical device technical files and standard client formats.
    • Compliance Review: Review legacy technical files to identify any gaps in compliance with MDD 93/42/EEC requirements, including areas such as product labeling, clinical evaluation reports, testing summaries, and essential requirements checklists.
    • Design Change Review: Assess design changes to ensure the legacy technical files accurately reflect the current design of the device, identifying any discrepancies.
    • Gap Analysis & Recommendations: Summarize identified gaps in regulatory compliance and recommend corrective actions.
    • Cross-functional Collaboration: Work with R&D, Quality, and Regulatory teams to achieve agreement on corrective actions needed to address compliance gaps.
    • Action Plan Development: Develop and track a plan to address compliance gaps, ensuring that actions are completed and documented accurately.
    • Ongoing Review: Continuously monitor and update the STED file as changes are made throughout the development process.
    • Global Registration Impact: Analyze and report the impact of updated STED content on global regulatory registrations.
    • Team Communication: Maintain and communicate progress during weekly team meetings to ensure project alignment and transparency.

    Qualifications & Skills:

    • Education: Bachelor’s degree in a science or related field.
    • Experience:
      • At least 5 years of relevant experience in regulatory affairs within the medical device industry.
      • In-depth knowledge of EU medical device regulatory requirements.
      • Proven experience working with Class IIb/IIa devices is mandatory.
      • Strong ability to work independently and manage tasks with minimal supervision.

    Additional Information:

    All personal information will be kept confidential in accordance with EEO guidelines.

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