Quality System Compliance Manager - Medical Device

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 Quality System Compliance Manager, you will lead our global compliance strategy and certification programs, ensuring our products meet or exceed international regulatory and safety requirements. You will serve as a key liaison between global product development, certification agencies, and executive leadership - driving a culture of safety, compliance, and continuous improvement across the organization.
You will be responsible for overseeing multiple product certification programs from concept through commercialization, managing risk proactively, and enabling global market access. In this senior leadership role, you'll build and guide a high-performing team, establish best practices, and influence product design decisions to align with both regulatory expectations and business objectives.
KEY RESPONSIBILITIES

• Strategic Leadership: Define and lead the company's global product safety and compliance strategy, ensuring alignment with business goals and regulatory requirements across all markets.

• Program Oversight: Direct multiple product certification initiatives from concept to mass production, establishing processes that ensure timely and successful market access.

• Regulatory Partnership: Serve as the primary point of contact with international regulatory and certification bodies; maintain up-to-date knowledge of global standards, certifications, and legislation.

• Risk Management: Develop and oversee risk assessment methodologies (including DFMEA processes), ensuring product safety is embedded throughout the product lifecycle.

• Cross-Functional Collaboration: Partner closely with engineering, product management, manufacturing, and quality teams to integrate compliance considerations into early design decisions.

• Governance & Reporting: Lead compliance reviews, status updates, and executive briefings, communicating complex technical and regulatory information effectively to senior leadership.

• Continuous Improvement: Champion process optimization, automation, and best practice sharing across global compliance operations.

• Team Development: Provide mentorship and leadership to engineers and specialists; build organizational capability in compliance, safety, and certification disciplines.

• Stakeholder Engagement: Represent the compliance function in product development reviews and business strategy discussions, balancing innovation with regulatory integrity.

QUALIFICATIONS & EXPERIENCE

• Bachelor's degree in Electrical, Mechanical, or Systems Engineering (Master's degree preferred).

• 8-10+ years of experience in product compliance, safety engineering, or regulatory affairs - including leadership experience in a global manufacturing or consumer electronics environment.

• Strong understanding of international product safety standards (UL, CE, FCC, IEC, etc.) and regulatory frameworks.

• Proven success managing certification programs and regulatory interactions across multiple product lines and geographies.

• Demonstrated experience leading cross-functional teams and managing complex, multi-stakeholder projects.

• Familiarity with DFMEA and other structured risk assessment methodologies.

• Excellent communication, influencing, and executive presentation skills.

• Strategic thinker with strong analytical and problem-solving abilities.

• Passion for mentoring and developing talent within a high-performance culture.

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
$131,900-$161,200 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
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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 [email protected]