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:
- 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.
- Conduct day to day regulatory & compliance activities, including but not limited to procurement and production.
- Plan, conduct and monitor testing and inspection of materials, as per regulatory compliance and products to ensure finished product quality
- Document internal audits and other regulatory activities
- Collect and compile statistical quality data and analyses them for improvement in the quality system as part of QMS.
- Identify training needs and organize training interventions to meet quality standards.
- Ensure the medical device products comply with the regulations of the regions where it is planned to be marketed and sold.
- Maintaining a good understanding of new and existing regulations, standards and guidances that may impact their organization’s products and processes.
- 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.
- Prepare submissions for regulatory registration and renewals
- Maintaining data and files on country registrations for future reference, particularly in the event of an audit by a regulatory agency
- Preparing for and supporting internal, regulatory, and third-party audits as necessary
- Collaborate with the project teams and explaining regulatory requirements, procedures, and policies to all employees and stakeholders as necessary.
- Able to work in cross functional teams with good communication & interpersonal skills
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 analysisQualification:
Ph.D. or masters with 5-7 years of experience, with experience in biologics and life science research products.