PMS Specialist
- Tata Elxsi
- 4 - 8 years
- Pune
- 3 days ago
- Email to a friend
- Report this job
Job Description
Role Overview:
We are seeking a highly experienced Post-Market Surveillance (PMS) Subject Matter Expert (SME) to join our Clinical and PMS Affairs team. This individual will play a pivotal role in driving PMS strategy, execution, and compliance for medical device clients across global regulatory frameworks. The SME will lead client-facing business pitches, train internal teams, review and approve PMS deliverables, and provide expert guidance on regulatory requirements and best practices for PMS.
Key Responsibilities:
Technical Expertise & Document Review
- Review PMS-related documents such as:
- PMS Plans
- PMS Reports
- Periodic Safety Update Reports (PSUR)
- Post-Market Clinical Follow-up (PMCF) Plans and Reports
- Ensure compliance with EU MDR, UK MDR, US FDA, and other applicable regional regulations.
- Provide expert opinions and recommendations for document improvements.
Training & Capability Building
- Develop and deliver training programs for internal teams on PMS processes, regulatory requirements, and documentation standards.
- Mentor team members to ensure high-quality PMS deliverables.
Regulatory & Quality Guidance
- Advise clients on PMS-related Quality Management System (QMS) elements and SOP development.
- Offer solutions for regulatory challenges and PMS process optimization.
Client Engagement & Business Development
- Represent the organization as a PMS expert during client pitches and solution presentations.
- Understand client pain points and propose tailored PMS solutions aligned with EU MDR, UK MDR, and US FDA requirements.
- Provide strategic input for proposals and Statements of Work (SOW).
Domain Development & Innovation
- Stay updated on global PMS regulations and emerging trends.
- Develop new frameworks, tools, and best practices for PMS implementation.
- Contribute to thought leadership in PMS thro
Job Classification
Industry: MiscellaneousFunctional Area / Department: OtherRole Category: OtherRole: OtherEmployement Type: Full timeContact Details:
Company: Tata ElxsiLocation(s): Pune
Keyskills: PMS EU MDR Post Market Surveillance PMCF PSUR
Similar positions
Tata Elxsi
Kuick Research is a market research and analytics company that provides targeted information for critical decisions at business, product and service levels. We are quick, predictive and known by the recommendations we have made in the past. Our result-oriented research methodology offers understandi...
Job Listings
We are in open beta version of website, please let us know if any issues, at: info(at)indigojobs.in