Global Regulatory Compliance Specialist

2 days ago

Bengaluru, Karnataka, India beBeeRegulatory Full time US$ 70,000 - US$ 1,20,000
Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The ideal candidate will have extensive knowledge of medical device regulations and standards, as well as experience in quality assurance or regulatory affairs.

Main Responsibilities:

  • Plan, coordinate and prepare document packages for regulatory submissions and renewals, with a focus on EU Technical Files, MDSAP, and other regulated countries.
  • Author technical file documentation to support EU MDR requirements.
  • Review product labelling (advertising, promotions, IFUs, claims, device labelling) for regulatory compliance.
  • Contribute to complaint handling process and prepare/submit MDRs and Incidents to appropriate health authorities.
  • Perform MDR gap assessments and remediation of MDD technical files.
  • Provide Regulatory support to Manufacturing and R&D to perform significant change impact assessments. Participate in Change Review board to review and approve Engineering Changes.
  • Develop and maintain Regulatory Information Management system.
  • Co-author regulatory plans for new product introduction or product line extensions.
  • Author Regulatory department procedures, templates.
  • Provide guidance, training, and direction on regulatory topics to teammates.
  • Maintain annual facility registrations, device listing, GSI, and GUDID as required by US FDA.

Requirements:

  • In-depth knowledge of medical device regulations and standards, such as FDA QSR, MDSAP, ISO 13485, (EU) MDR 2017/745, and ISO 14971.
  • Experience in Ophthalmology or surgical instrument field preferred.
  • Experience in medical device development, quality assurance, or regulatory affairs is highly desirable.
  • Strong analytical and problem-solving skills with the ability to assess complex technical issues.
  • Excellent communication and collaboration skills to work effectively with cross-functional teams.
  • Detail-oriented and well-organized, with the ability to manage multiple tasks and priorities simultaneously.
  • Familiarity with documentation and submission requirements for regulatory bodies is an advantage.

Qualifications:

  • BS/BA in Engineering, Life Sciences, or an equivalent technical field.
  • MS in Regulatory Affairs or RA/QA certifications a plus.

Experience:

  • 5-8 years of experience in Quality or a regulated industry is preferred.

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