Regulatory Affairs Associate

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 3,600+ associates, the company's products are sold at key retailers, online and offline, and through distributors around the world.
The Regulatory Affairs Associate is responsible for managing the intake, documentation, and routing of customer complaints within the organization's Quality Management System (QMS). This role ensures that all customer complaints and feedback are tracked accurately and processed in compliance with internal procedures, ISO 13485, and applicable regulatory requirements. This position is technical and is focused on process adherence, and regulatory documentation as well as the complaints investigation.
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Key Responsibilities:
Complaint Intake & Documentation:
Lead medical device complaint management process.
Set up processes to intake new complaints and product feedback from designated sources (customer service portals, email, phone logs, online forms)• Review submissions for completeness and follow up with internal stakeholders to collect any missing required information.• Accurately log complaints in the QMS, ensuring each entry meets procedural and regulatory standards.
Workflow Management:• Initiate and route complaint records to the appropriate stakeholders (e.g., quality, engineering, regulatory) for further action and investigation.• Monitor the status of open complaints and ensure timely progression through all required stages (e.g., intake, initial assessment, investigation, closure).• Ensure all complaint-related records, attachments, and decision rationales are properly documented and traceable.
Quality System Compliance:• Ensure complaints are processed in accordance with company procedures and applicable regulations.• Confirm required reviews, approvals, and effectiveness checks are completed prior to complaint closure.• Support internal audits and inspections by preparing complaint files and records as requested.
Regulatory Support:• Identify complaints that may involve reportable events and escalate to the appropriate personnel for regulatory assessment.• Maintain documentation needed to support complaint reporting activities for regulatory authorities.
Reporting & Communication:• Generate routine and ad hoc complaint summary reports for management and quality teams.• Provide updates on complaint trends and open complaint status during team meetings or quality reviews.• Collaborate with customer service, Return logistics, and QA/RA teams to facilitate efficient complaint processing.
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Qualifications:
Bachelor or Masters degree in a health, life sciences, business, or quality-related field preferred.• 1-3 years of experience in a quality, compliance, or customer service support role, preferably in a regulated industry (medical device, pharmaceutical, healthcare).• Experience working with electronic or paper-based QMS platforms (e.g., MasterControl, Veeva, Greenlight Guru, TrackWise, or equivalent).• Familiarity with ISO 13485, FDA 21 CFR 820, and complaint handling best practices is highly desirable.
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Skills and Competencies:• Excellent attention to detail and organizational skills.• Strong verbal and written communication.• Proficiency in using document management systems, spreadsheets, and collaborative tools.• Ability to manage multiple tasks and meet deadlines with minimal supervision.• Comfortable working in a fast-paced, regulated environment with a focus on compliance and accuracy.
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
$66,330-$81,070 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]