Post Market Surveillance / Regulatory Coordinator

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.