Post Market Surveillance Specialist

Job Description

Job Title : Post Market Surveillance Specialist

Job Responsibilities:

Post Market Surveillance (PMS)

u2022 Ensures standard PMS processes across business units
u2022 Assures consistent PMS plans exists for all products
u2022 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)
u2022 Assures consistent PMS Reports across business units

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Patient Safety and Regulatory Reporting

u2022 In collaboration with Medical Affairs, monitors and assesses safety signals, and recommends actions
u2022 Assesses product relationship to reported complaint.
u2022 Assures standard regulatory reporting assessment criteria
u2022 Provides input to clinical conclusion to be included in the reports to competent authorities

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Risk Management

u2022 Support standard RM processes
u2022 In collaboration with stakeholders, defines standard risk acceptability criteria (RAC) with stakeholders
u2022 Supports the development of consistent RM plans exists for all products
u2022 Assures consistent RM plans exists for all products
u2022 Provides oversight and clinical guidance on risk assessments including post-market risk assessments and health hazard evaluations

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PMS and RM Governance

• Assures standard PMS and RM governance across Business Units

• Provides oversight of PMS and RM processes and assures standard approach

• Signal Assessment & Escalation:

• Ensures standard statistical trending techniques

• Assesses significant triggers & safety concerns.

• Manage recurrent PMS/RM data review meetings

• Assures standard approach for signal disposition

• Incorporate findings in PMS reports and updated RM files as required

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PMS and RM input into Product Development

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u2022 Represent PMS interests in multi-disciplinary teams during product development.
u2022 Assures development and completion of PMS & RM deliverables throughout the design process
u2022 Provides input of PMS related product risk & quality issues during the development of new products

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Technical Knowledge andu00A0Skills required

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• Bacheloru2019s degree in engineering or equivalent

• 8 to 10 years of experience in the medical device industry

• PMS experience in Medtech industry - Mandatory

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OTHER DESIRABLE KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:

u2022 Demonstrates collaborative patient and customer focus
u2022 Regulatory Affairs, Quality Assurance, or Complaint Handling experience in pharmaceuticals or medical devices
u2022 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.
u2022 Experience interacting with the FDA, ISO, and Other Regulatory Authorities preferred.
u2022 English proficiency oral and written must have adequate computer skills to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate.
u2022 Excellent communications and analytical skills
u2022 Project management skills preferred
u2022 In depth knowledge of medical terminology preferred
u2022 Understanding of statistical fundamentals is preferred
u2022 Experience with health hazard evaluations is preferred

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the companyu2019s facilities. Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 locations.
About Philips
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If youu2019re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our .