Sr. Post Market Surveillance Specialist – Treace

Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders. Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. 

The Sr. Post Market Surveillance Specialist (Remote) will be responsible for management and execution of complaint handling and MDR submissions. The Product Surveillance Specialist shall have prior experience working within an FDA compliant Title 21 section 820 and 803 environment and the ability to work cross functionally to support rapid growth and continuous improvement. Will be required to come into the Headquarters for training and occasional meetings as needed.

What you will be doing in the role:

• Assess information from all product experience data sources with accuracy and discern high risk complaints for escalation in accordance with regulatory requirements and company policy
• Perform follow-up communication and correspondence with patients and medical professionals in alignment with regulatory requirements and company policy
• Document results of completed complaint investigations, and product evaluations to facilitate complaint closure with management
• Determine MDR reportability and files MDRs in compliance with Title 21 section 803 requirements
• Assist in root cause investigations and corrective actions issued through the internal CAPA system
• Communicate with engineering regarding product quality and investigations with vendors
• Assist with field action communication/correspondence and procures required field action records from customers as required
• Participates in quality system audits (FDA, ISO, Internal, etc.)

What you will bring to the role:

• Bachelors degree preferred; (Science, Engineering, Nursing); Associates degree required
• Five (5) years of experience in Medical Device Quality/Regulatory Compliance function; equivalent experience relevant to the role will be considered in lieu of Medical Device and/or Regulatory experience
• Strong familiarity working within an FDA compliant Title 21 section 820 and 803 environment
• Intermediate MS Excel skills

It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law.

It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law.