Description: 

The Director of Product Monitoring & Post‑Market Surveillance (PMS) leads the global strategy and operations that ensure the safety, quality, and performance of the company's biologics–device combination products following commercialization. This role oversees complaint handling, adverse event reporting, annual product quality reviews, post‑market surveillance analytics, field actions, and signal detection activities while ensuring compliance with FDA, EMA, and global regulations.

Location: Warren, New Jersey - 3 days on site & 2 days remote

Salary Range: 200k-235k

Key Responsibilities: 

• Develop and execute global product monitoring and PMS strategy for combination products.

• Lead post-market professionals responsible for the timely and effective handling, management, preparation,

• and assembly of information for complaint determination, complaint evaluation, vigilance reporting, field action/recall executions and APQR management.

• Comply with established global regulations and procedures for complaint and reportable event handling (post-market vigilance) to ensure timely, uniform, and accurate complaint processing and issuance of initial, supplemental, and final reports to regulatory agencies for reportable events.

• Lead Annual Product Quality Reviews (APQR) and ensure integration of complaint trends, field performance, CAPA effectiveness, and stability data.

• Ensure compliance with 21 CFR Part 4, 820, 211, 6xx, ISO 13485 & ISO 14971.

• Collaborate cross‑functionally with Medical Affairs, Regulatory, Quality Engineering, Quality Risk Management,

• Operations, and other functional areas to enable and continuously improve customer experience and support improvements throughout the product lifecycle.

• Conduct signal detection and trending analysis for emerging risks and ensure escalation and cross-functional engagement with stakeholders around the world to enable rapid response to emerging issues and opportunities.

• This position will require approximately 20% travel to France.
  

Qualifications: 

• Bachelor’s degree in a relevant field (e.g., engineering, life sciences, quality management) with an advanced degree preferred. Regulatory and/or Quality Assurance certifications are a plus.

• Minimum of 10 -12 years of increasing responsibility in a biotechnology/pharmaceutical, GxP-related Quality & Compliance environment.

• Combination product, medical device, drug, and/or biologics experience is preferred. · Minimum 7 - 10 years direct and indirect management level experience, including senior-level project planning and working/managing in a global environment.

• Experience leading complaint handling and regulatory reporting programs.

• Experience in leading/managing field actions/recalls.

• Deep expertise in global PMS and APQR requirements.

• Strong knowledge of ISO 14971, root cause tools, and regulatory compliance

• Experience working with global teams.

• Experience within 1 or more eQMS platforms for 5+ years (Veeva/ENNOV desired).

Technical & Functional Skills:

• Extensive knowledge, understanding, and practical implementation of FDA, ICH, and other GXP requirements to develop, maintain, and expand a comprehensive product monitoring and post-market surveillance program at a biotechnology company.

• Experience and practical expertise in developing and implementing Quality Management Systems and Governance meeting the requirements of FDA 21 CFR 211/820, ICH Q8, 9, and 10, and ISO 13485; 21 CFR part 6xx desired

• Knowledge of design controls and human factors.

• Strong written and verbal communication skills, analytical problem-solving, and conflict resolution skills to manage and support a cross-functional Team and global organization.

• Flexible, highly motivated, with strong organizational skills and the ability to multitask.

• Must be able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic environment. (This is a senior-level position that also requires a hands-on, direct management and ownership approach with the PM Team. This is not a strategic and/or management-only position.)

• Ability to work independently and to make decisions based on experience.

• Effective interpersonal skills.

• Fluent in English reading, writing, and speaking is a must; fluency in French is a plus.

Behavioral skills: 

• Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”,

• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,

• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,

• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.