ClinChoice, a global life sciences and regulatory consulting organization, is hiring a Senior Associate – Regulatory Affairs (EU MDR) in Bengaluru, India. This opportunity is ideal for regulatory professionals with hands-on experience in EU MDR (2017/745), Technical File (TF)/Design Dossier (DD) management, and medical device compliance.
If you are looking to advance your career in EU MDR regulatory affairs jobs in India, this role offers strong exposure to global submissions, cross-functional collaboration, and high-impact regulatory projects.
Key Responsibilities – EU MDR Regulatory Affairs
As a Senior Associate – Regulatory Affairs (EU MDR), you will:
- Collaborate closely with client regulatory project teams to collect and maintain Technical File (TF) and Design Dossier (DD) documentation under EU MDR 2017/745
- Identify applicable regulatory requirements, harmonized standards, MDCG guidance documents, and submission expectations
- Review, compile, and organize regulatory documents from PLM and regulatory systems into compliant Adobe PDF formats
- Create bookmarks and indexes and upload finalized documentation into PLM via Change Orders
- Perform quality control (QC) checks to ensure completeness, correct pagination, and absence of missing or blank pages
- Coordinate with cross-functional teams and affiliates to obtain legal and compliance documents such as:
- Certificate to Foreign Government (CFG)
- Certificate of Free Sale (CFS)
- Respond to health authority and affiliate queries related to EU MDR submissions
- Represent Regulatory Affairs on project meetings and report regulatory requirements, timelines, and deliverables
- Communicate routinely with regulatory management on project status
- Support additional regulatory and compliance activities as assigned
Eligibility & Qualifications
To qualify for this EU MDR Regulatory Affairs job at ClinChoice, candidates must have:
- Bachelor’s degree in Life Sciences or a related discipline
- Minimum 1 year of experience in Regulatory Affairs – EU MDR
- Mandatory knowledge of:
- EU MDR (2017/745)
- ISO 13485
- FDA Medical Device Regulations
- Strong working knowledge of Microsoft Word, Excel, and PowerPoint
- Excellent written and verbal English communication skills
- Experience with PLM systems and document lifecycle management is an advantage
Why Join ClinChoice?
- Work with a global regulatory consulting organization
- Hands-on exposure to EU MDR medical device submissions
- Opportunity to collaborate with international clients and affiliates
- Strong career growth in medical device regulatory affairs
- Hybrid work environment with structured regulatory processes
Job Location
📍 Bengaluru, Karnataka, India
Salary Range (Estimated)
💰 ₹6,00,000 – ₹10,00,000 per annum
(Salary may vary based on experience, regulatory expertise, and interview performance)
How to Apply
