Regulatory Affairs Manager

10 - 15 years

0 Lacs

Posted:4 days ago| Platform: Linkedin logo

Apply

Work Mode

On-site

Job Type

Full Time

Job Description

Designation: Regulatory Affairs Manager


Industry: Medical Devices (Orthopedic inactive devices preferred)

Experience required: 10 to 15 Years


Location: Sanand, Ahmedabad



Company overview:


A globally‑recognized orthopedic medical device firm founded in 2003, delivering cutting-edge sports‑medicine and extremities implants and instruments across six continents

Driven by innovation, quality and clinical value, the team remains privately held and proudly owned, maintaining a collaborative, family‑style culture.



Duties and Responsibilities:


  • Responsible for strategic development, implementation, maintenance, and overall success of the company’s regulatory project approvals in different countries.


  • Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business Strategy.


  • Global coordination for regulatory planning and execution, for the development and market introduction of Company Products


  • Regulatory compliance and medical device registration in Asia, Africa, ANZ, Middle East, Europe and LATAM countries. Management of a team of RA coordinators for different countries.


  • Draft, review, edit, and maintain all departmental policies and procedures, including Post approval changes, regulatory review of order, label and IFU requirements, Language translation needs, Marketing claims etc.




Take charge of your next career move!

Ansuya@uhr.co.in




Contact Person

Ansuya Satish / Anjali Batheja

9824350317 / 9723300064

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview
cta

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

coding practice

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now

RecommendedJobs for You

Kukatpalli, Telangana, India