Lead RA, Global QRC On-Market Sustainment
The Lead Regulatory Affairs Specialist at Cepheid will drive global regulatory strategies for product lifecycle management and on-market sustainment. This role involves leading regulatory engagements for global changes, performing complex assessments, and supporting QMS activities such as audits and CAPAs. Candidates must have extensive experience in the IVD or medical device sector with deep knowledge of global regulatory frameworks. The position provides a platform for strategic impact across international health authorities.
50k new jobs listed every day. Install TAL to find more jobs like this.
Experience
6+ years
Function
Engineering
Work mode
Onsite, India
Company
Tier 2
What you will work on
The Lead Regulatory Affairs Specialist at Cepheid will drive global regulatory strategies for product lifecycle management and on-market sustainment. This role involves leading regulatory engagements for global changes, performing complex assessments, and supporting QMS activities such as audits and CAPAs. Candidates must have extensive experience in the IVD or medical device sector with deep knowledge of global regulatory frameworks. The position provides a platform for strategic impact across international health authorities.
TAL's take
Strong role with a reputable life sciences organization (Danaher subsidiary) focusing on complex global regulatory strategy.
The JD clearly defines the role within the QRC On-market Sustainment team, specifying responsibilities and regulatory compliance frameworks.
Must haves
- Bachelor's degree with 8 years or Master's with 6 years experience
- Experience in IVD or Medical Device industry
- Familiarity with global regulatory frameworks
- Knowledge of global product registration processes
- Ability to interpret regulatory intelligence
Tools and skills
Nice to have: product lifecycle strategies, market access planning.
About the company
Cepheid is a major subsidiary of Danaher, a respected global life sciences conglomerate.