Associate Regulatory Affairs Jobs at ClinChoice EU MDR medical devices in Bengaluru for life sciences graduates with EU MDR experience.
Company Overview
ClinChoice is a globally recognized life sciences and regulatory consulting organization providing specialized services across clinical development, regulatory affairs, pharmacovigilance, and medical device compliance. The company supports pharmaceutical, biotechnology, and medical device manufacturers worldwide by helping them meet complex regulatory requirements across multiple regions. Associate Regulatory Affairs Jobs
With a strong footprint in global regulatory submissions and compliance strategy, ClinChoice offers professionals the opportunity to work on high-impact international projects. To strengthen its medical device regulatory team in India, the organization is hiring a Regulatory Affairs professional with hands-on experience in EU MDR compliance. Associate Regulatory Affairs Jobs
Job Location & Employment Type
- Job Location: Bengaluru, Karnataka
- Employment Type: Full-time
- Work Mode: Hybrid / Office-based (as per project needs)
- Functional Area: Regulatory Affairs – Medical Devices
Open Positions / Department Details
- Position Title: Associate / Senior Associate – Regulatory Affairs (EU MDR Medical Devices)
- Department: Medical Device Regulatory Affairs
- Regulatory Focus: EU MDR (Regulation (EU) 2017/745)
- Experience Level: Minimum 1 year
This role is designed for regulatory professionals involved in EU MDR documentation, Technical File management, and regulatory lifecycle activities for medical devices. Associate Regulatory Affairs Jobs
Key Roles & Responsibilities
The selected candidate will support EU MDR regulatory activities for global medical device clients. Key responsibilities include: Associate Regulatory Affairs Jobs
- Working closely with client regulatory project teams to identify, collect, and maintain Technical File (TF) and Design Dossier (DD) documentation
- Interpreting and applying EU MDR (2017/745) requirements along with MDCG guidance documents
- Identifying applicable regulatory pathways, harmonized standards, and submission expectations
- Reviewing, compiling, and organizing regulatory documents sourced from PLM or similar document management systems
- Converting and structuring regulatory documentation into compliant Adobe PDF formats
- Creating accurate bookmarks, indexes, and file structures for regulatory submissions
- Uploading finalized documentation into PLM systems through approved change control processes
- Performing quality control checks to ensure document completeness, correct pagination, and data accuracy
- Coordinating with cross-functional teams and global affiliates to obtain legal and compliance documents such as:
- Certificate to Foreign Government (CFG)
- Certificate of Free Sale (CFS)
- Other supporting regulatory certificates
- Responding to regulatory queries from health authorities and regional affiliates
- Representing the Regulatory Affairs function during project meetings
- Communicating regulatory timelines, requirements, and deliverables to stakeholders
- Providing regular project updates to regulatory management
- Supporting additional regulatory compliance activities as assigned
Eligibility Criteria
Education
- Bachelor’s degree in:
- Life Sciences
- Biomedical Sciences
- Pharmacy
- Biotechnology
- Engineering or related scientific disciplines
Experience
- Minimum 1 year of experience in Regulatory Affairs with a focus on EU MDR medical devices
Skills Required
- Mandatory working knowledge of:
- EU MDR (Regulation (EU) 2017/745)
- ISO 13485 Quality Management Systems
- FDA Medical Device Regulations
- Experience handling Technical Files and Design Dossiers
- Familiarity with PLM systems and document lifecycle management
- Strong proficiency in Microsoft Word, Excel, and PowerPoint
- Excellent written and spoken English communication skills
- High attention to detail and documentation accuracy
- Ability to coordinate with cross-functional and international teams
- Strong organizational and time-management skills
Associate Regulatory Affairs Jobs
Salary & Benefits
- Estimated Salary Range: ₹6,00,000 – ₹10,00,000 per annum
(Compensation may vary based on experience, regulatory expertise, and interview performance)
Additional benefits may include:
- Exposure to global EU MDR medical device submissions
- Opportunity to work with international clients and regulatory authorities
- Structured regulatory processes and knowledge sharing
- Strong career growth in medical device regulatory affairs
- Collaborative and professional work environment
Selection Process
The hiring process may include:
- Resume shortlisting based on EU MDR experience
- Technical interview focused on medical device regulations
- HR discussion and final selection
The process may vary depending on project requirements.
How to Apply
- Mode of Application: Online Application Only
Interested candidates should apply through the official application link provided by ClinChoice. Walk-in or email applications are not specified for this role. Associate Regulatory Affairs Jobs
Important Dates
- Last Date to Apply: Not specified (early application recommended)
Why Apply for This Pharma Job?
This role is ideal for regulatory professionals seeking to deepen their expertise in EU MDR medical device compliance. Working with ClinChoice offers direct involvement in global regulatory submissions, exposure to international regulatory expectations, and long-term growth opportunities in one of the fastest-growing regulatory domains. Associate Regulatory Affairs Jobs
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent pharmaceutical and medical device job information platform. We are not affiliated with ClinChoice or any other organization mentioned. All job details are shared for informational purposes only. Candidates should verify information directly through official company channels before applying. Associate Regulatory Affairs Jobs
Final Call-to-Action
If you have experience in EU MDR regulatory affairs and are ready to work on global medical device projects, apply now and advance your regulatory career with ClinChoice. Associate Regulatory Affairs Jobs
