Sr. Regulatory Affairs Officer Jobs in Mumbai - Surgimedik Healthcare
Job Description
- Co-ordination and preparation of necessary documentation and reports for Medical Device technical files, and operation of the file review and maintenance system.
- Compliance activities for the Medical Device products. Indian and International.
- Regulatory participation in Medical Device Project work and Notified Body audits when necessary.
- To support QA, helping to ensure that our ISO 13485 accreditation is maintained.
- To maintain a knowledge and familiarity with current regulatory requirements for all aspects of the job.
- To support the Regulatory Team Leader in the reporting and analysis of the departmental performance.
- To attend as required appropriate industry regulatory meetings, also self-learn
- Degree in Life Sciences or equivalent.
- Prior experience within a regulatory function covering Medical Devices, minimum 2 years.
- Working knowledge ISO 13485 regulations.
Job Particulars
Role others
Education BSc
Who can apply Experienced (2 Years)
Hiring Process Face to Face Interview, Telephonic Interview
Employment TypeFull Time
Job Id436537
Job Category BSc/BCA/BBM , Analyst / Analytics , Logistics / Transportation
Locality Address Kandivali West
State Maharashtra
Country India
About Company
SURGIMEDIK manufactures and market products for Urology, Gastroenterology, Women's Health, Nephrology, Interventional Radiology, and Oncology.
SURGIMEDIK is ISO 13485 : 2012 , ISO 13485:2003 certified and most of the devices manufactured are CE certified.
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