Product Event Coordinator

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).

Position Summary:

The Product Event Coordinator will act as the primary notification and consolidation point for receiving, processing, analyzing and reporting product events including product complaints and adverse events. This position will process intake information and communicate to internal customers (Pharmacovigilance, Regulatory and Quality). Manage customers related to intake information (e.g., emails, phone calls), and maintenance of event files.

Schedule:

This position is in-office Monday-Friday in our Cambridge, MA location.

Position Scope:

• Manage the product event process including initial intake or receipt of event information from all sources, associated clarification communication and data entry into product event tracking systems.
• Assess product event information provided, check for accuracy and content, gather any missing information for the event file and escalate to appropriate internal functions as needed.
• Manage timeline expectations per regulatory and policy requirements following intake and through the product event life cycle.
• Establish which department(s) to assign event and follow-up for status and for event closure.
• Maintain product event files pursuant to internal procedures.
• Escalate customer concerns to the next level of management where appropriate.
• Assure timely completion of product event process according to internal policies and applicable regulations.
• Support facilitation of returned products, if applicable.
• May perform other duties as required.

Qualifications:

• BA or BS degree preferred and/or combination of education and relative experience in lieu of a degree
• 5-7 years' experience working in medical device and/or pharmaceutical industry preferred
• Previous product event intake and handling experience
• Awareness of medical device, pharmaceutical and biologic regulatory requirements preferred
• Detailed oriented and proven ability to multi-task
• Ability to take ownership and think independently, be motivated, and self-directed
• Must be able to communicate precisely and accurately
• Strong interpersonal and project management skills
• Excellent written and verbal communication skills
• Works well in a team environment

Why Vericel?

• Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
• Career Growth: Be a part of a growing organization with opportunities to expand your impact.
• Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.

EEO Statement

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.