Sr. Manager - Regulatory Affairs

Sr. Manager - Regulatory Affairs

Siemens Technology
Vadodara India
5-7 years
Not Specified

Job Description


Job Description :
Job Summary:
Candidate should have experience in Regulatory, , ​quality inspection, auditing and process as per in country regulations and export markets.
Responsibilities & Duties:
  1. Interpret and implement quality assurance standards and procedures with proven competencies to MDR-17, EU MDR, MDD, CE IVDR, Clinical evaluation reports, 510(K), 21CFR 820-QSR and sound understanding of regulations at US, Canada EU, ASEAN countries and Australia.
  2. Conduct day to day regulatory & compliance activities, including but not limited to procurement and production.
  3. Plan, conduct and monitor testing and inspection of materials, as per regulatory compliance and products to ensure finished product quality
  4. Document internal audits and other regulatory activities
  5. Collect and compile statistical quality data and analyses them for improvement in the quality system as part of QMS.
  6. Identify training needs and organize training interventions to meet quality standards.
  7. Ensure the medical device products comply with the regulations of the regions where it is planned to be marketed and sold.
  8. Maintaining a good understanding of new and existing regulations, standards and guidances that may impact their organization’s products and processes.
  9. Collect, collate and evaluate product specific information in order to create and update the dossiers that must be submitted for new product licenses and license renewals.
  10. Prepare submissions for regulatory registration and renewals
  11. Maintaining data and files on country registrations for future reference, particularly in the event of an audit by a regulatory agency
  12. Preparing for and supporting internal, regulatory, and third-party audits as necessary
  13. Collaborate with the project teams and explaining regulatory requirements, procedures, and policies to all employees and stakeholders as necessary.
  14. Able to work in cross functional teams with good communication & interpersonal skills

Job Requirements:
Experience:
Working experience in a Regulatory & Manufacturing setup with ISO13485 and CAPA/PMS.
Product licensing & documentation as per MDR-17, EU MDR, MDD, CE IVDR,
Product or industry-specific experience to Molecular Biology/Biologics
Knowledge of Microsoft Office, QA applications and databases
Adept at data analysis tools and statistical analysis
Qualification: Ph.D. or masters with 5-7 years of experience, with experience in biologics and life science research products.

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