Post Market Surveillance Associate

2 weeks ago

Palo Alto, United States a Medical Device company near Monroe, CT Full time

Post Market Surveillance Associate


RESPONSIBILITIES

  • Managing day-to-day operations and collaborating across departments.
  • Communicating information through the department email inbox.
  • Executing field action tasks, including translations, mailings, and tracking.
  • Collaborating with cross-functional teams to collect data and complete documents.
  • Ensuring ongoing regulatory compliance and driving continuous product and process improvements.
  • Support Post Market Surveillance by partnering with sales teams, QA, manufacturing, and other relevant teams.
  • Issuing Return Merchandise Authorizations (RMAs) for product returns as needed.
  • Managing the shared email inbox and Requests for Additional Information (RFAI).
  • Filing all documentation for Health Hazard Evaluations (HHEs) and Field Actions.
  • Ensuring reporting requirements comply with company policy and applicable laws and regulations worldwide.
  • Meeting and maintaining department metrics aligned with company goals.
  • Supporting and maintaining compliance with disposition and reporting activities globally.


QUALIFICATIONS

  • Minimum 1 year of Regulatory experience.
  • Minimum 3 years of Quality Management Systems experience.
  • Project Manager experience is a plus.
  • CAPA Management lead/owner experience is a plus.
  • Prior experience in a global organization/team.
  • Related experience in Correction & Removal processes, regulatory submissions, Risk Management, and/or project management, preferably in the medical device or similar industry.
  • Ideal candidates will have direct correction and removal experience within the medical device industry, particularly with software.
  • Strong organizational skills.
  • Ability to communicate effectively with stakeholders.
  • Ability to manage multiple projects/tasks with initiative.
  • Flexibility to adapt to change.
  • Excellent verbal and written communication skills.
  • Good understanding of Quality Management Systems and associated interrelationships.
  • Knowledge of FDA regulations 21 CFR 806, 820, ISO standards 13485, Health Canada, and EU MDR 2017/745 and MDCG 2023-3.


EDUCATION

  • Bachelor’s degree in Biomedical Science or related discipline.

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