Postmarket Surveillance Manager

Description

The Investigation Unit Manager plays a critical role in ensuring the continued safety, quality, and performance of products after market release. This management position oversees a team responsible for investigating potential quality-related issues identified through customer complaints, trend monitoring and other post-market surveillance activities. The manager will guide the team in analyzing data, investigating potential field actions, and collaborating with cross-functional partners to assess risk. They will ensure timely and effective communication of findings and recommendations to internal and external stakeholders. Key responsibilities include managing team operations such as onboarding, training, work assignment, and performance reviews. The manager will also provide hands-on support to team members as needed and may participate in corrective and preventive actions (CAPA), audits, and regulatory inspections. A strong understanding of applicable regulations and standards is essential, as the manager will be expected to make informed decisions regarding current procedures and lead efforts to evaluate and implement procedural updates.

Primary Duties:

1. Perform all work in compliance with company policy and within the guidelines of bioMerieux’s Quality System.

2. Directly supervises staff, which includes hiring, orienting, onboarding, training, assigning and reviewing work performance, annual work performance appraisals, and discipline.

3. Stay updated on global regulations related to post market quality.

4. Draft and own departmental procedures (SOPs and work instruction documents and associated templates).

5. Monitor departmental key performance indicators (KPIs) and analyze for opportunities to optimize performance.

6. Prepare presentations for post market quality updates.

7. Represent post market quality in cross-functional projects or teams.

8. Manage improvement projects, as needed.

9. Foster a culture of continuous improvement throughout the organization.

10. Represent post market quality during regulatory inspections and audits, as needed.

11. Performs other duties as assigned.

Training, skills and Education:

• Bachelors Degree (ideally in Biology, Biochemistry, Immunology, Microbiology, Chemistry, Biomedical Engineering, Medical Lab Science, Biotechnology or other Scientific Fields) with 6 years of experience in a regulated medical device/IVD industry employment position such as post-market surveillance, quality assurance, regulatory affairs, clinical affairs or product development
• OR
• Masters Degree (ideally in Biology, Biochemistry, Immunology, Microbiology, Chemistry, Biomedical Engineering, Medical Lab Science, Biotechnology or other Scientific Fields) with 4years of experience in a regulated medical device/IVD industry employment position such as post-market surveillance, quality assurance, regulatory affairs, clinical affairs or product development
• 3+ years leading or coordinating teams/projects preferred
• Previous experience investigating to root cause; utilization of investigation methods and tools
• Ability to align post-market quality initiatives with broader quality goals and regulatory landscapes.
• Deep understanding of global medical device/IVD regulations (e.g., FDA 803/806, MEDDEV, QSR 820, ISO 13485) and the ability to interpret and apply them effectively.
• Skilled in hiring, onboarding, coaching, and developing high-performing teams. Experience in setting expectations, conducting evaluations, and managing performance improvement. Skilled in analyzing KPIs and driving continuous improvement initiatives.
• Ability to guide and support peers and direct reports through technical and professional growth. Strong ability to lead and manage quality-related projects from initiation to completion.
• Personable and service oriented with attention to detail, excellent organizational and time management skills.
• Foster and sustain robust, productive, cross-functional relationships with teams in R&D, Quality (Quality Assurance/Quality Control), Manufacturing, Customer Service, and other departments.
• Excellent written and verbal communication skills, including justification for post market quality related decisions or processes.
• Ability to prioritize and manage multiple tasks effectively in a fast-paced environment. The ability to work closely with management to identify and communicate areas of technical, schedule, and budget risk.
• Ability to guide, mentor and develop team members.
• Ability to work well within a cross-functional team environment.
• Capable to complete work in a time-sensitive environment.