What are the responsibilities and job description for the Regulatory Affairs Project Manager I position at TekOne IT Services Pvt. Ltd.?
Role: Regulatory Affairs Project Manager I
Location: Santa Clara, CA
Duration: 12 Months on W2 (Possible extension)
Shift Timings: 8 AM to 5 PM
Skills Looking For
Location: Santa Clara, CA
Duration: 12 Months on W2 (Possible extension)
Shift Timings: 8 AM to 5 PM
Skills Looking For
- Regulatory Affairs Project Manager.
- Experience in Regulatory affairs in either: Domestic experience: FDA or International experience: under VDR regulations or Working with other International Countries around the world.
- They must be able to work with cross-functional teams.
- Working with Quality and technical representatives to represent the regulatory function on project teams going through medical device product development.
- Experience working with medical devices. Class I and II medical device experience.
- Being a Regulatory lead on projects and having a regulatory mentality and perspective in providing team feedback.
- Regulatory Affairs experience is more crucial than compared to project management experience.
- Do regulatory assessment on the design plans that are coming through to understand the impact to our functions for changes that teams want to make to the product; Also work on International technical files for compliance for IVDR and updating those files to ensure they stay in compliance; Sit on project teams and handle meetings to ensure all tasks are completed in given timeline and provide necessary feedback, Regulatory functions that happen every week- review changes that come through, review changes to labels etc
- Bachelor's degree in life sciences or engineering with a minimum of 5 years of core regulatory experience.
- Phone screening followed by panel in-person interview.
