Medical Safety and Complaints Manager

We are a mission-driven company redefining what's possible in cardiac care. As we continue to scale, we're seeking a clinically astute and strategic Manager, Medical Safety and Complaints-an experienced Nurse Practitioner (NP) in cardiology or electrophysiology-to lead a high-performing team responsible for post-market surveillance, complaint evaluation, and patient safety initiatives.

Reporting into medical leadership, you'll play a critical role in ensuring that every product experience is assessed through a clinical lens, with the goal of improving outcomes, enhancing patient trust, and meeting global regulatory expectations.

What You'll Do

• Lead & Develop Clinical Talent: Manage a growing team of RNs and other clinical professionals responsible for complaint review, clinical investigations, and reportability assessments.

• Provide Clinical Oversight: Review and sign off on complex or high-risk cases, ensuring consistent application of clinical judgment and regulatory standards.

• Drive Operational Excellence: Optimize workflows, complaint handling processes, and documentation standards to support efficient and compliant safety operations.

• Partner Cross-Functionally: Serve as a key liaison to Quality, Regulatory Affairs, Product, and R&D teams-ensuring clinical clarity and safety strategy alignment across functions.

• Enhance Safety Signal Detection: Lead clinical trending and signal detection efforts by interpreting complaint and surveillance data through a cardiology-focused lens.

• Advance Clinical Strategy: Contribute to strategic safety initiatives, including risk/benefit assessments, labeling updates, and design feedback loops.

• Champion Education & Consistency: Provide training, mentorship, and clinical frameworks for decision-making to ensure high-quality outputs and professional growth within the team.

• Support Regulatory Interactions: Collaborate with Regulatory Affairs to support inspections, audits, and safety-related inquiries from authorities such as the FDA and global health agencies.

About You

• Clinical Credentials: Licensed NP with cardiology or electrophysiology specialization. Master's or Doctorate in Nursing preferred.

• Experience: 7+ years of clinical experience, including direct care in cardiac populations. At least 3-5 years in medical device safety, complaints handling, or clinical quality leadership roles.

• Leadership Ability: Prior experience mentoring or managing clinical teams in a regulated healthcare or MedTech setting.

• Regulatory Fluency: Strong knowledge of 21 CFR 803/820, ISO 13485, MEDDEV 2.12/1, and global post-market surveillance requirements.

• Strategic Thinking: Proven ability to connect day-to-day complaint management with long-term safety strategy and product improvement.

• Communication Skills: Strong written and verbal communicator, capable of interfacing with clinical and technical audiences alike.

• Collaborative Spirit: You value partnerships across disciplines and bring a thoughtful, team-first approach to problem solving.

• Mission-Driven: You are committed to improving patient safety and care quality, and thrive in a fast-paced, high-impact environment.

You'll Love This Role If You:

• Are a clinical leader who wants to shape safety practices across a category-defining product portfolio.

• Want to elevate clinical decision-making within a growing and empowered team.

• See medical safety as a strategic asset-not just a regulatory requirement.

• Thrive at the intersection of clinical care, technology, and innovation.

Join us in setting a new standard for post-market medical vigilance in digital health and cardiac monitoring.