About Us:

BIOTEK is a global medical device company focusing on current product development in the most advanced Orthopaedic sector: SPORTS MEDICINE. With presence on all six continents worldwide, the growth and demand for our products around the globe is unprecedented.
We are looking for Urgent requirement of Deputy Manager-Regulatory Affairs to join our team
As a Deputy Manager- Regulatory Affairs, you will play a pivotal role in shaping our company's regulatory approach, from product inception through to market launch. You will collaborate closely with cross-functional teams to ensure that all regulatory requirements are met, while also keeping abreast of evolving regulations and industry trends. Your ability to provide clear, actionable insights and maintain strong relationships with regulatory bodies will be key to driving our success in a highly regulated industry.

Location: Ahmedabad

Experience: Atleast 8 Years of experience in medical device regulatory domain, with exposure to FDA 510(k) submission

Duties and Responsibilities:
Responsible for strategic development,



implementation, maintenance, and overall success of the company’s regulatory project approvals in different countries.
Develop and implement regulatory strategies to ensure timely market access and compliance with US FDA, EU MDR, ISO 13485, and other global regulatory bodies.
Regulatory affairs strategy and coordination with Internal and external team for Asia, Africa, ANZ, Middle East, Europe and LATAM countries.
Oversee the preparation and submission of regulatory dossiers, including FDA 510(k), PMA, CE marking, and international registrations.
Lead and maintain the company’s QMS, ensuring compliance with ISO 13485, MDSAP, ISO 14971, FDA QMSR and other applicable standards.
Coordinate with the Sales & Marketing team for business continuity and center of contact for all regulatory matters.
Manage regulatory interactions with government agencies – FDA for Q-sub, Pre-sub meetings, and notified bodi

📌 Deputy Manager/ Assistant Manager (Ahmedabad)
🏢 Chetan Meditech - India
📍 Ahmedabad