Mhr - Regulatory Affairs & QA - Healthcare

Discipline - Healthcare and Life Sciences

Subsector - Regulatory Affairs & Compliance

Location - Chennai

About our Client - Our client is one of the leading providers of image solutions in oncology and pain care. Some of their new launches would be a game changer in Interventional oncology. They are looking for a Manager-Regulatory Affairs & QA to be based out of their headquarters in Chennai

Job Description - Reporting to the Director-Regulatory Affairs, your responsibilities will include. Regulatory Certifications for all Class II medical equipment and Class III devices for global markets.

- Work closely with QA, V&V, Product Development, Product Management and Technology teams.

- Overseeing the regulatory reporting, site audits, etc.

- Participate in clinical trial design, usablity studies, marketing collateral review etc

- Ensure absolute compliance with the co-owners.

The Successful Candidate - You are a BS/Msc in Engineering, with 10 years experience in regulatory filing for IDE, 510(k), CE, SF DA etc. You have hands on experience in creating submission filings, V&V with V&V with expert level working knowledge of US, EU, China, Japan, APAC, Canada and Latin America regulatory requirements. You have excellent interpersonal, communication and leadership skills.

What's on Offer - Work with one of the leading companies in the medical devices space.

- Compensation is between 12 - 15 lakhs.

The Apply Button will redirect you to Michael Page's website. Please apply there as well.