Associate Director Postmarket Surveillance

Manchester, NH
Full Time
Quality
Senior Manager/Supervisor

About Sequel 

Sequel, headquartered in Manchester, New Hampshire, is a company developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel’s approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all.
 Sequel’s flagship product, the twiist Automated Insulin Delivery (AID) System, launched in July 2025 for people with type 1 diabetes providing them with personalized diabetes management.   

Job Overview 

Sequel is seeking an experienced and strategic Associate Director, Postmarket Surveillance to lead and mature our post market surveillance (PMS) function during a critical phase of growth and product scaling. This individual will drive the development, execution, and continuous improvement of Sequel’s global PMS strategy—ensuring compliance, patient safety, and actionable insights that inform product and process enhancements. 

Reporting to the Director of Clinical Quality & Postmarket Surveillance, the Associate Director will serve as a key cross-functional leader, collaborating closely with Quality, Regulatory, Clinical, R&D, IT, and Customer Care teams. This role demands both a systems-level thinker and a hands-on leader capable of building scalable processes, leading teams, interpreting complex data, and representing Sequel with regulatory authorities. 

Job Responsibilities and Essential Duties 

Strategic Leadership & System Design: 
  • Own and evolve Sequel’s global Postmarket Surveillance strategy, ensuring robust alignment with FDA, EU MDR, ISO 13485, and QMSR 2026 requirements. 
  • Lead the implementation of digital solutions (e.g., automation, AI-enhanced surveillance tools) to enhance the efficiency and effectiveness of PMS activities. 
  • Serve as the subject matter expert for PMS during audits, inspections, and regulatory submissions. 
Complaint Handling & Signal Management: 
  • Oversee end-to-end complaint intake, investigation, escalation, documentation, and closure processes. 
  • Drive signal detection and trend analysis to identify systemic issues and drive proactive quality and safety improvements. 
  • Interface with internal stakeholders and cross-functional teams to communicate complaint trends and inform risk management, design changes, and CAPA activities. 
Regulatory Compliance & Adverse Event Reporting: 
  • Ensure timely and accurate reporting of adverse events, malfunctions, and field actions (e.g., MDRs, vigilance reports, recalls) to global regulatory bodies. 
  • Develop regulatory strategies for PMS-related communications in partnership with Regulatory Affairs. 
Team Leadership & Talent Development:
  • As required by business needs, build and lead a high-performing PMS team by hiring, coaching, and mentoring quality professionals. 
  • Foster a culture of accountability, quality, and continuous improvement within the PMS function and across the broader organization. 
Cross-Functional Collaboration & Influence:
  • Collaborate with R&D, Medical Affairs, Clinical, Customer Care, and Commercial teams to integrate post market insights into product lifecycle management. 
  • Actively contribute to Quality Management Reviews and executive-level reporting on PMS performance, metrics and risk trends. 

Minimum Requirements 

  • Bachelor's degree in a relevant field preferred (Master's degree strongly preferred).  
  • 8+ years of progressive quality management experience in the medical device industry, with a strong focus on Complaint Handling, Adverse Event Reporting, and Post Market Surveillance preferred.  
  • 2+ years of experience leading and developing teams.  

Required Knowledge, Skills and Abilities 

  • Proficiency with tools such as Veeva Vault, Veeva QMS, Veeva PromoMats, and complaint handling systems. 
  • Demonstrated experience preparing communications for FDA, European Competent Authorities, and other regulatory agencies. 
  • Deep knowledge of relevant regulatory frameworks: 21 CFR Part 820, 803, 806, ISO 13485, ISO 14971, EU MDR, QMSR 2026. 
  • Strong critical thinking and analytical skills, with experience applying root cause analysis and statistical tools. 
  • Excellent written and verbal communication skills, including comfort presenting to senior leadership and regulators. 
  • Self-starter with the ability to thrive in a fast-paced, startup environment that values agility, innovation, and transparency. 
  • Ability to work on-site at Sequel’s Manchester, NH headquarters. 
  • Willingness to travel (up to 15%) as business needs require. 

Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. 

Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.  

At Sequel, we believe that when you thrive, we thrive. That’s why we’ve designed a benefits package that’s as thoughtful as it is generous. From day one, you’re automatically enrolled in our 401k plan—no waiting, no worries—with a 6% company match and 100% immediate vesting. We prioritize your well-being, especially for our employees and their families living with diabetes, with capped out-of-pocket insulin costs and GLP-1 coverage across all plans. With multiple medical plans through Aetna, including a 100% company-paid high-deductible plan paired with employer HSA contributions, you can select what suits your needs. Additional benefits include vision and dental plans, employer-paid short-term disability, and voluntary options like accident and pet insurance. 

Environmental/Safety/Physical Work Conditions 

  • Ensures environmental consciousness and safe practices are exhibited in decisions 
  • Use of computer and telephone equipment and other related office accessories/devices to complete assignments 
  • May work extended hours during peak business cycles 
  • Physical requirements such as lifting specific weights 
  • Some travelling is expected 
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