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16/04 Vicky
TA at Cross Bridges

Views:265 Applications:19 Rec. Actions:Recruiter Actions:0

Leadership Role - Post Market Surveillance - Medical Devices (15-25 yrs)

Pune Job Code: 27148

ROLES AND RESPONSIBILITIES :

Post Market Surveillance (PMS) :

- Ensures standard PMS processes across business units

- Assures consistent PMS plans exists for all products

- Assures consistent and standard process exists to perform proactive surveillance (e.g. regulatory database searches, literature reviews) and reactive surveillance (e.g. complaints handling, field actions)

- Assures consistent PMS Reports across business units

Patient Safety and Regulatory Reporting :

- In collaboration with Medical Affairs, monitors and assesses safety signals, and recommends actions

- Assesses product relationship to reported complaint.

- Assures standard regulatory reporting assessment criteria

- Provides input to clinical conclusion to be included in the reports to competent authorities

Risk Management :

- Support standard RM processes across DI

- In collaboration with stakeholders, defines standard RAC with stakeholders

- Supports the development of consistent RM plans exists for all products

- Assures consistent RM plans exists for all products

- Provides oversight and clinical guidance on risk assessments including post-market risk assessments and health hazard evaluations

PMS and RM Governance :

- Assures standard PMS and RM governance across Business Units

- Provides oversight of PMS and RM processes and assures standard approach across DI

- Signal Assessment & Escalation :

a. Ensures standard statistical trending techniques

b. Assesses significant triggers & safety concerns.

c. Manage recurrent PMS/RM data review meetings

d. Assures standard approach for signal disposition

e, Incorporate findings in PMS reports and updated RM files as required

PMS and RM input into Product Development :

- Represent PMS interests in multi-disciplinary teams during product development.

- Assures development and completion of PMS & RM deliverables throughout the design process

- Provides input of PMS related product risk & quality issues during the development of new products

REQUIRED EXPERIENCE :

- Bachelor's degree in health science or similar healthcare-related field, such as Medical Doctor MD, Nursing, Radiology, Registered Pharmacist (RPH), or equivalent (4 year degree required; additional education is desirable)

- 15+ yrs of Industry experience

- 6 to 8 years of experience in the pharmaceutical / medical device industry or direct device clinical experience

- Experience supervising others is desirable

REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES :

- Demonstrates collaborative patient and customer focus

- Regulatory Affairs, Quality Assurance, or Complaint Handling experience in pharmaceuticals or medical devices

- Must have direct experience/knowledge of most regulations relative to PMS activities and reporting, such as: ISO 13485/14971, FDA Regulations (21CFR (803, 806, 82, etc.)), CMDR, JPAL, Medical Devices Directive (93/42/eec, 98/79/EC)), and EU MDR is preferred.

- Experience interacting with the FDA, ISO, and Other Regulatory Authorities

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

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