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    Senior Regulatory Affairs Specialist

    Arevna
    3+ years
    Not Disclosed
    Boston Remote, USA
    10 Nov. 14, 2024
    Job Description
    Job Type: Full Time Remote 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: Senior Regulatory Specialist - Medical Device Submissions (Remote, USA or Canada)

    Overview of the Role:
    The Senior Regulatory Specialist plays a crucial role in providing comprehensive regulatory expertise to support daily departmental operations. Working closely with the Manager of Regulatory Affairs, this role focuses on managing global medical device registrations and ensuring the department’s compliance with regulatory policies. Key responsibilities include leading regulatory submissions, such as CERs for EU MDR, managing responses to regulatory authorities, and collaborating with global teams to support all aspects of regulatory affairs.

    Location:
    Remote (USA or Canada)

    Time Zone Requirements:
    CST or EST only

    Citizenship Requirement:
    U.S. Citizenship required

    Key Responsibilities:

    • Lead regulatory submissions including CER, CDP, CEP, PMCFP, SSCP, and Technical Documentation for EU MDR Class III.
    • Handle 510(k) submissions (post-2022) with eSTAR experience.
    • Manage global medical device registration processes, ensuring compliance with regulations such as FDA and EU MDR.
    • Collaborate with cross-functional global teams and regulatory authorities.
    • Oversee electronic and paper-based documentation management.
    • Provide leadership solutions in challenging situations and support compliance for global regulatory requirements.

    Qualifications:
    Education/Training/Certifications:

    • Bachelor’s or Master’s degree with 5+ years of experience in medical device regulatory submissions (fields like regulatory science, biology, chemistry, clinical research, or paralegal studies).
    • Alternatively, 3+ years of experience with an advanced degree (PhD, PharmD, EdD, DBA, or D.Eng.).
    • Regulatory Affairs Certification (RAC) preferred.

    Experience Requirements:

    • Primary author for documents such as CDP, CER, PMCFP, SSCP, and Technical Documentation for EU MDR Class III, and experience with 510(k) submissions (post-2022, eSTAR required).
    • Proven international registration experience, particularly with CE MDR.
    • Familiarity with full lifecycle regulatory affairs processes, including complaint handling and regulatory reportability (FDA, MDR, and other regulatory bodies).
    • Knowledge of regulatory requirements in regions like China (NMPA) and LATAM preferred.

    Skills and Abilities:

    • Strong technical and scientific writing skills with experience as a primary author.
    • Ability to interpret and apply country-specific regulatory requirements globally.
    • Thorough understanding of 510(k) and CE MDR processes, FDA/EU MDR standards for medical device submissions, and labeling requirements (IFUs, labels).
    • Excellent verbal communication skills for leadership and handling regulatory challenges.
    • Proficiency with MS Office, Adobe Acrobat, and document management software.
    • Ability to manage multiple priorities in a fast-paced environment and work independently with minimal supervision in a remote setting.

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