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Regulatory Affairs Analyst

Regulatory Affairs Analyst

Varex Imaging Corporationthane, maharashtra, in
1 day ago
Job 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 :

Job Description

  • 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.

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

    • What we offer

  • A unique opportunity to become part of growing organization in India being part of a global market leader in Xray imaging components.
  • Excellent development potential
  • An international work environment with global teams collaborating on various projects across several countries.
  • Competitive compensation package including participation in Varex incentive plans
  • Corporate Health Benefits
  • Additional benefits will be added as we grow
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    Analyst • thane, maharashtra, in