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Regulatory Affairs Analyst

Regulatory Affairs Analyst

Varex Imaging Corporationpune, India
5 hours ago
Job description

Description

Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the following :

  • Keeps abreast of medical device regulatory procedures, medical device safety standards and changes in global regulations.
  • Strong working knowledge of FDA regulations, UK, EU, ISO13485, Brazil, Australia, China, Japan, Canada, and Rest of World
  • Compiles all materials required in submissions, license renewal and annual registrations to FDA, Health Canada, China NMPA, and other international authorities.
  • Supports global product registrations, including the compilation and maintenance of regulatory dossiers, technical documentation, and country-specific submission materials.
  • Performs device classification assessments in accordance with regulatory frameworks in the U.S., Canada, EU, China, and other global markets
  • Maintains strong understanding of country-specific documentation and regulatory expectations for product submissions, compliance, and import / export.
  • Prepares and provides Certificates of Compliance, Declarations of Conformity, and other supporting compliance documents for internal and external stakeholders.
  • Participates in post-market surveillance, GMP compliance, 3rd party audits, inspections, reviews and approves advertising and promotions materials.
  • Recommends changes for labeling, manufacturing, marketing, and usability protocols for medical device regulatory compliance.
  • Participate as team member to plan, develop, and implement regulatory strategy throughout the medical device product lifecycle.
  • Reviews and approves design outputs.
  • Uses regulatory information and knowledge to integrate regulatory perspectives into the organization, its policies, and procedures.
  • Reviews, approves, and recommends changes for labeling, manufacturing, marketing, and test protocols for regulatory compliance and / or approval.
  • Compiles and maintains technical files for medical device products
  • Participates in hosting / assisting with external audits from Notified Bodies, and Product Safety Agencies

Required Skills and Experiences

  • Bachelor’s Degree in life sciences, engineering, regulatory compliance,
  • 2+ years of experience in regulatory compliance in the medical device industry and medical device safety standards.
  • 2+ years of experience driving related medical device safety standards into design requirements.
  • 2+ years of experience completing multiple submissions across health authorities.
  • Experience with Class I, II, and / or III medical devices and industrial products (including experience determining device classifications globally).
  • Proven track record of preparing and managing regulatory submissions (e.g., FDA 510(k), Health Canada License Applications, EU Technical Files, NMPA dossiers, etc.).
  • Experience supporting product registrations and certifications across multiple international markets.
  • Microsoft Office / ERP / QMS Software competency
  • Employee must be able to meet the following requirements with or without an accommodation.
  • Sedentary or light work that may occasionally require employee to lift / move up to 20 lbs.
  • Reaching above and below the shoulder occasionally.
  • Wear personal protective equipment (PPE) as required.
  • Travel to other locations may be requested.

    • Time Type : Full time

    Job Type : Regular

    Work Shift : N / A

    Pay Rate Type : Salary

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    Analyst • pune, India