Product Compliance & Post-Market Surveillance Specialist

LausanneTemporaireChimie, Pharma, Biotechnologie2019-06-26Master / Université
We are recruiting on behalf of our client a

Product Compliance & Post-Market Surveillance Specialist

Responsibilities

• Monitor and manage the overall complaint processing work flow to ensure timely processing of complaints.
• Review complaints and assess for reportability and potential impact to patient safety and business operations.
• Identify complaints requiring investigation and coordinate cross-functional tasks to facilitate complaint investigations.
• Communicate with internal staff, field staff and global partners as required to support complaint activities.
• Review complaint documentation to ensure that all required activities are properly completed and documented prior to complaint closure.
• Respond to customer inquiries regarding product complaint and resolutions and prepare customer communications for specific complaints as required.
• Conduct cross functional complaint meetings at regular intervals to provide a forum for complaint resolutions.
• Maintain complaint handling procedures in accordance with the FDA quality system regulation, ISO 13485 and the applicable regulatory requirements.
• Monitor complaints for adverse trends and report as necessary.
• Provide complaint data for ongoing reports and in response to internal requests.
• Generate complaint trending reports for analysis.

Profile

Minimum:
• 2-4 years medical device industry experience in Customer Support or Complaint Handling
• BA or BS degree or a combination of education and experience providing equivalent knowledge
• Working knowledge and experience with quality systems regulations and guidelines, ISO 13485, and FDA quality system regulations 21CFR 820.
• Ability to read, analyze and interpret common scientific, technical journals, regulatory communications and complaint data.
• Ability to respond to common inquiries or complaints from customers,
• Ability to develop clear, concise, and timely oral and written reports.
• Demonstrated proficiency with Microsoft Excel.
• Well Organized and multitasking capabilities
• English excellent.

Preferred:
• Experience or knowledge of filing MDRs and international vigilance reports.
• Communicate effectively and tactfully with all levels of personnel.

Other:
• Detail oriented, often with multiple priorities. The environment is deadline sensitive and may be exposed to high-pressure situations.

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