Medical Device Complaints Manager

Описание вакансии

About Us 

SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people’s lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja, the company has a proven track record of bringing disruptive innovation to market and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains. Headquartered in Needham, Massachusetts with more than 4,100 associates, the company’s products are sold at key retailers, online and offline, and through distributors around the world.

As the Medical Device Complaints Manager, you will lead the design, execution, and continuous improvement of SharkNinja’s global medical device complaints and post-market surveillance processes. This role is accountable for ensuring complaints are consistently captured, investigated, trended, and escalated in compliance with global regulatory requirements—while remaining tightly integrated with SharkNinja’s customer experience and consumer electronics operating model. 

You will establish and operate a complaints process that is risk-based, scalable, and audit-ready, aligned to device classification and global market requirements. Partnering closely with Customer Experience, Core Quality, NPD Quality, Engineering, Regulatory, Legal, and Product teams, you will ensure post-market signals are translated into meaningful corrective actions, risk mitigation, and product improvements—supporting both patient safety and rapid innovation at scale. 

Key Responsibilities 

• Own and evolve the global medical device complaints and post-market surveillance process, ensuring compliance with 21 CFR Part 820 / FDA QMSR, ISO 13485, EU MDR, and other applicable global requirements.

• Design and maintain a risk-based, scalable complaints framework aligned to device classification, product complexity, and SharkNinja’s global market footprint.

• Oversee complaint intake, triage, investigation, escalation, and closure, ensuring timely, thorough, and compliant handling across all regions.

• Lead adverse event assessment and vigilance reporting, including FDA MDRs, EU MDR PMS/Vigilance reporting, and other country-specific submissions as required.

• Establish and monitor complaints metrics, trending, and dashboards, identifying systemic issues, emerging risks, and early warning signals.

• Ensure complaints data feeds effectively into CAPA, risk management, and product improvement activities, partnering closely with Core Quality, NPD Quality, Engineering, and Product teams.

• Coordinate technical investigations and root cause analyses with Core Quality, Engineering, Product Development, and Customer Experience teams.

• Lead and support medical device recalls, field actions, and safety communications, and serve as the primary complaints and post-market subject matter expert during audits and regulatory inspections.

Qualifications & Experience 

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related technical discipline.

• 7–10+ years of experience in medical device complaints handling, post-market surveillance, vigilance, or quality systems, preferably within consumer electronics, electromechanical devices, or high-velocity product environments.

• Demonstrated experience designing, operating, and scaling medical device complaints and post-market processes compliant with 21 CFR Part 820 / FDA QMSR, ISO 13485, and EU MDR.

• Strong hands-on experience with complaint investigations, adverse event reporting, vigilance submissions, trending, and CAPA integration.

• Experience authoring and maintaining EU MDR post-market documentation, including PMS plans/reports and PSURs (as applicable).

• Proven experience supporting or leading medical device recalls and field actions, including cross-functional coordination and regulatory communication.

• Strong cross-functional influence and communication skills, with the ability to translate post-market data into actionable quality, product, and risk decisions.

• Experience managing or leading complaints or post-market teams.

• Pragmatic, risk-based mindset with a proven ability to operationalize post-market compliance in fast-paced, consumer-driven environments.

Salary and Other Compensation: The annual salary range for this position is displayed below. Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate. 

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, flexible spending accounts, health savings accounts (HSA) with company contribution, 401(k) retirement plan with matching, employee stock purchase program, life insurance, AD&D, short-term disability insurance, long-term disability insurance, generous paid time off, company holidays, parental leave, identity theft protection, pet insurance, pre-paid legal insurance, back-up child and eldercare days, product discounts, referral bonus program, and more.

Pay Range

$111,800—$136,600 USD

Our Culture

At SharkNinja, we don’t just raise the bar—we push past it every single day.  Our Outrageously Extraordinary mindset drives us to tackle the impossible, push boundaries, and deliver results that others only dream of. If you thrive on breaking out of your swim lane, you’ll be right at home.

What We Offer

We offer competitive health insurance, retirement plans, paid time off, employee stock purchase options, wellness programs, SharkNinja product discounts, and more. We empower your personal and professional growth with high impact Learning Programs featuring bold voices redefining what’s possible. When you join, you’re not just part of a company—you’re part of an outrageously extraordinary community. Together, we won’t just launch products—we’ll disrupt entire markets.  

At SharkNinja, Diversity, Equity, and Inclusion are vital to our global success. Valuing each unique voice and blending all of our diverse skills strengthens SharkNinja’s innovation every day. We support ALL associates in bringing their authentic selves to work, making an impact, and having the opportunity for career acceleration. With help from our leadership, associates, and our community, we aim to have equity be a key component of the SharkNinja DNA. 

Learn more about us:  

Life At SharkNinja  

Outrageously Extraordinary

SharkNinja Candidate Privacy Notice

• For candidates based in all regions, please refer to this Candidate Privacy Notice.
• For candidates based in China, please refer to this Candidate Privacy Notice.
• For candidates based in Vietnam, please refer to this Candidate Privacy Notice.

We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, disability, or any other class protected by legislation, and local law. SharkNinja will consider reasonable accommodations consistent with legislation, and local law. If you require a reasonable accommodation to participate in the job application or interview process, please contact SharkNinja People & Culture at accommodations@sharkninja.com