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Post Market Surveillance and Complaint Handling

 

Description

Post-Market Surveillance (PMS) Specialist

Description

Do you want to be part of a team responsible for the post-market activities related to combination products in Europe, America, Asia, and Australia?

Are you committed to ensure that medical devices placed on the market are safe and effective, interested to work in a challenging regulatory environment involving interface with drug regulations, and willing to expand your post-market surveillance expertise?

Then you may be the person we are looking for to join our growing team in Phillips-Medisize’s Global Innovation & Development Center based in Virum and Struer.

What You Will Do In Your Role?

As a Post-Market Surveillance (PMS) Specialist, you will:

Be the owner and subject matter expert regarding the Post-Market Surveillance process:

  • Identify and implement requirements from new markets, based on business needs.
  • Maintain, update, and improve the process (procedures, and templates).
  • Define relevant information to be included in the PMS process.
  • Coordinate information exchange between Phillips-Medisize and its customers.
  • Identify the suitable data processing method(s) to extract meaningful data.
  • Set-up and maintain the PMS Plan for each product.
  • Coordinate data collection and analysis with internal stakeholders.
  • Perform reporting according to regulatory requirements (e.g. PMSR; PSUR, …)
  • Train/Educate stakeholders (internal and external) on PMS requirements.
  • Provide input in quality agreement regarding post-approval activities.
  • Participate in internal and external audits.

Be the owner and subject matter expert regarding complaint and vigilance process:

  • Identify and implement requirements from new markets, based on business needs.
  • Maintain, update, and improve the processes (procedures, and templates).
  • Advise and coordinate information exchange process between stakeholders.
  • Document complaint handling and reporting process for specific customers.
  • Train/Educate complaint handling team on process and incident identification.
  • Train/Educate stakeholders regarding the vigilance process.
  • Collaborate with the PRRC in case of reportable events.
  • Participate in internal and external audits.

The Experience You Will Bring

  • Bachelor’s degree in life science or engineering.
  • Proven experience in a similar role in the medical device industry.
  • Deep understand of the Medical Device Regulation (EU) 2017/745, and medical device development standards such as ISO 13485, ISO 14971.
  • Willingness, and ability to quickly acquire new knowledge.
  • Pragmatic and holistic approach toward regulatory interpretation and implementation.
  • Systematic, rigorous, and structured thinking and documentation.
  • Strong organizational skills, and the ability for multi-tasking.
  • Pro-activity, self-drive and commitment to process improvement.
  • Ability to work in an evolving, challenging, and multi-disciplinary environment.
  • Excellent written and verbal communication skills in English.
  • Proficiency with MS Office.
  • Ability to understand and translate customer requirements.
  • Ability to vulgarize regulatory and complex topic to communicate with naive audience.

What Will Put You Ahead

  • Experience with PMS, complaint handling and vigilance in foreign countries
  • Knowledge of data processing technics (trending, statistical analysis, MTBF, Pareto).

What We Offer

  • Opportunity to join a growing team working in a fast pace and multidisciplinary environment.
  • Collaborate with the regulatory department of leading pharmaceutical companies around the world.
  • Mobile Phone
  • Broadband connection at home
  • Private health insurance
  • Competitive pension scheme

 Phillips-Medisize A/S is part of the Pharmaceutical and Medical Division of Molex, a leader in the design, development and delivery of advanced drug delivery devices and connected health solutions.Phillips-Medisize A/S is collaborating with leading pharmaceutical companies worldwide by offering innovative and integrated solutions supported by an end-to-end service from Strategy to Launch. Read more about Phillips-Medisize A/S at phillipsmedisize.com.\

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