Regulatory Affairs Specialist
Company: Rangam Consultants Inc.
Posted on: January 25, 2023
Term & Start
---12-18 month--- Start ASAP--- Location: Pleasanton, CA
Title: Senior Regulatory Affairs Specialist
The contingent worker should be a self-starter, requiring minimum
supervision on dailyactivities. He/She should have hands on
experience in the review/approval of change orders in PLM (e.g.
Agile or Windchill), labeling changes and labeling requirement
assessment, and other routine regulatory tasks.
- Provide regulatory support for Rebranding, Labeling and
Packaging Update Projects for Heart Failure products
- Initiate, Review and Approve Change Orders related to various
- Communicate with International Regulatory Affairs affiliates
and provide adequate information for initiating Regulatory
- Navigate and provide regulatory input to the develop approaches
for Packaging and labeling updates
- Supports a collaborative environment to align with other cross
- Active follow-up on the progression of day-to-day documentation
activities required to successfully and timely complete the
- Supports the Technical Publications team to update Labels and
IFUs and align with the requirements
- Supports the Packaging team to update Packaging design and
drawings and align with the requirements
- Stay abreast of all pertinent regulatory affairs/ quality
system issues specific to projects
- Applies skill set to navigate through the various regulatory
operations activities as necessaryMandatory Requirements
- Medical Device Regulatory Affairs (2+ years)
- B.S. in Engineering or Life sciences or an alternative
Bachelor's degree program with experience in Engineering or Life
- A Masters degree in Regulatory Affairs can substitute for years
- Cross functional understanding of Design Control, Packaging,
Labeling, Risk Management, Clinical Affairs as required to support
Rangam Consultants is a minority, women-owned, disability workforce
solutions global organization. Specialized in attracting and
retaining talents globally for a rewarding career in IT,
Engineering, Scientific, Clinical, Healthcare, Administrative,
Finance, Business Management, and many more, while integrating
veterans and individuals with disabilities into the workforce.
Indeed, we connect career aspirants to relevant job opportunities,
be it jobs in USA, UK, India, or Ireland. Also remote jobs,
work-from-home jobs, or contract jobs in different verticals and
Rangam strives to put job seekers first, giving them free access to
search for jobs, post resumes, and research companies.Every day, we
connect millions of people to new opportunities.
Keywords: Rangam Consultants Inc., Pleasanton , Regulatory Affairs Specialist, Other , Pleasanton, California
Didn't find what you're looking for? Search again!