Subject Matter Expert(Medical device)

2 days ago

Bengaluru, Karnataka, India Celegence Systems Full time ₹ 12,00,000 - ₹ 36,00,000 per year

ROLE : Senior Subject Matter Expert(Medical Device)

Experience : 8-12 years

Job location: Jayanagar(Hybrid)

Core Requirements

1. Regulatory Expertise and Document Quality

  • Deep knowledge of Medical Device Regulations: You must be proficient in specific medical device regulations, primarily MEDDEV 2.7/1 Revision 4 and the EU Medical Device Regulation (MDR).
  • High-Quality Regulatory Document Development: The ability to develop and deliver various sections of high-quality regulatory documents (like Clinical Evaluation Reports, Summary of Safety and Clinical Performance, etc., though not explicitly named) that are fully compliant with the above regulations.
  • Scientific and Technical Accuracy: Ensuring all documents are scientifically accurate and technically sound, likely involving a strong understanding of medical devices across different therapeutic areas.

2. Consulting and Advisory Skills

  • Regulatory Consulting: Providing advisory consulting to customers on regulatory requirements.
  • Audit Response/Resolution: The ability to understand and effectively address observations from regulatory audits.

3. Collaboration and Communication

  • Cross-Functional Engagement: Actively engaging and collaborating with a wide range of internal and client-side cross-functional teams. This list is extensive and includes:

  • Medical Devices functional heads

  • Senior SMEs/Project Managers
  • Medical device writers(I & II)

  • Regulatory Affairs

  • Communication Delivery: Planning and delivering intra-departmental and cross-functional communication to ensure critical information is shared promptly.

4. Project and Team Management

  • Project Planning and Scheduling: Assisting in the development of schedules to ensure timely delivery and helping the Team Lead/Manager with planning.
  • Timeline Management: Proactively managing timelines for document creation and delivery.
  • Expectation Management: Communicating clearly with team members to maintain awareness of expectations, milestones, and deliverables.
  • Mentoring and Training: The ability to train and mentor junior members of the team on both technical and process-related aspects.

The ideal candidate is someone who is a:

  1. Regulatory Expert (EU MDR, MEDDEV 2.7/1 Rev. 4).
  2. Skilled Technical Writer/Developer of complex regulatory documentation.
  3. Consultant who can guide clients on compliance and audit responses.
  4. Strong Communicator and Collaborator across diverse technical and clinical teams.
  5. Strong accountability over deliverables .
  6. Proactive Project Manager/Mentor focused on quality and on-time delivery.

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