Regulatory Affairs Specialist
About Us reputed company is a global product design and technology company, with a reputed company 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 reputed company 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 Specialist is responsible for coordinating the intake, documentation, and routing of customer complaints reputed company the organization's Quality Management System (QMS). This role ensures that reputed company customer complaints and feedback are recorded accurately and processed in compliance with internal procedures, ISO 13485, and applicable regulatory requirements. This position is non-technical and is focused on administrative accuracy, process adherence, and regulatory documentation rather than product investigation. - -- Key Responsibilities: Complaint Intake & Documentation:• Monitor designated sources (customer service portals, email, phone logs, online forms) for new complaints and product feedback.• 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 Coordination:• Initiate and reputed company 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 reputed company required stages (e.g., intake, initial assessment, investigation, closure).• Ensure reputed company complaint-reputed company 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.• Assist in maintaining documentation needed to support complaint reporting activities for regulatory authorities. Reporting & Communication:• Generate routine and reputed company 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. - -- Qualifications:• High school diploma or equivalent required; Bachelor or Masters degree in a health, life sciences, business, or quality-reputed company 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 reputed company-based QMS platforms (e.g., reputed company, Veeva, reputed company, TrackWise, or equivalent).• Familiarity with ISO 13485, FDA 21 CFR 820, and complaint handling best practices is highly desirable. - -- 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 reputed company starting pay reputed company 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 reputed company, we don't just reputed company the bar-we push past it every single day. Our Outrageously Extraordinary reputed company drives us to tackle the impossible, push boundaries, and deliver results that others only dream of. If you reputed company on breaking out of your swim lane, you'll be reputed company. reputed company Offer We offer competitive health insurance, retirement plans, paid time off, employee stock purchase options, wellness programs, reputed company product discounts, and more. We reputed company your personal and professional growth with high impact Learning Programs featuring bold voices redefining what's possible. reputed company 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 reputed company, Diversity, Equity, and Inclusion are vital to our global success. Valuing each unique voice and blending reputed company of our diverse skills strengthens reputed company's innovation every day. We support reputed company 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 reputed company DNA. Learn more about us: Life At reputed company Outrageously Extraordinary reputed company Candidate Privacy Notice
- For candidates based in reputed company 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 reputed company, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, disability, or any other class protected by legislation, and local law. reputed company 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 reputed company People & Culture at accommodations@reputed company.com Apply tot his job Apply To this Job