Regulatory Compliance Manager
3 weeks ago
The Company
NULIFE is brought to you by MRK Healthcare, an ISO-13485 certified medical disposables company, which has been serving humanity for 59 years. Headquartered in Mumbai, we have 4 locations across India with a network of more than 3000 channel partners.
Nulife products are sold globally in over 80 countries and enjoy a global reputation for products that offer superior protection, high levels of comfort and performance. Our products comply with all the global standards like European CE mark under the new MDR (Medical Device Regulation), US510(k), South Korea GMP, etc.
Job Description - Senior Regulatory Compliance Manger
Job Description:
- Maintain regulatory files. Maintain and update regulatory authorizations, such as euMDR, 510(k), UCKA PPE & medical device licenses. etc. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes, and Support approval in other regions as required.
- Ensure the Quality Management System complies with the Drugs and Cosmetics Act, Medical Device Rule 2017 & Medical Device Regulations, and is effectively established, maintained, and efficient.
- Manage internal and external audits, inspection readiness, and Regulatory Authority inspections.
- Ensuring personal and company compliance with local regulations, policies, and procedures.
- Managing the complete PMS (post-market surveillance) process.
- Managed product and process risk management, clinical evaluation, product verification, and validation.
- Provide training to concerned employees related to ISO, MDR, GMP, and Medical device regulations as per EU and assessment.
- Assess device-related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities on time. Handle recalls and field actions, if required.
- Review and approve translations of product labelling (e.g., labels, IFU, user manual) and promotional material (external and internal communication).
- Understand local labelling requirements and ensure all activities related to product labelling are performed correctly.
- Ensure compliance with Environmental regulations.
- *Regulatory audits readiness.
Education:
B. Pharmacy/M. Pharmacy/B.Sc. /M.Sc.
Key skill:
Audit management euMDR, ISO13485 and 510K.
Work Experience:
5 years to 10 years
Languages:
English, Hindi and Gujrati
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