Regulatory Affairs Specialist

reputed company reputed company is a global product design and technology company, with a reputed company portfolio of 5-reputed company rated lifestyle solutions that positively reputed company people's lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja, reputed company has a proven reputed company record of bringing disruptive innovation to market, and developing one consumer product after another has allowed reputed company to reputed company multiple product categories, driving significant reputed company and market reputed company reputed company. Headquartered in Needham, Massachusetts with more than 3,600+ associates, reputed 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 reputed company 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 reputed company 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 reputed company entry meets procedural and regulatory standards. Workflow Coordination:• Initiate and reputed company complaint records to the appropriate stakeholders (e.g., reputed company, engineering, regulatory) for reputed company reputed company and investigation.• Monitor the status of reputed company complaints and ensure reputed company 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. reputed company 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 reputed company reports for management and reputed company teams.• reputed company updates on complaint trends and reputed company complaint status during team meetings or reputed company 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 reputed company-reputed company field preferred.• 1-3 years of experience in a reputed company, compliance, or customer service support role, preferably in a regulated industry (medical device, pharmaceutical, reputed company).• Experience working with electronic or reputed company-based QMS platforms (e.g., reputed company, reputed company, 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 reputed company tools.• Ability to manage multiple tasks and meet deadlines with minimal supervision.• Comfortable working in a fast-paced, regulated environment with a reputed company on compliance and accuracy. - -- Salary and Other Compensation: The annual salary reputed company for this position is displayed below. Factors which may reputed company starting pay reputed company this reputed company may include geography/market, skills, education, experience and other qualifications of the successful candidate. reputed company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, reputed company 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 reputed company time off, company holidays, parental leave, identity theft protection, pet insurance, reputed company-reputed company reputed company insurance, back-up child and eldercare days, product discounts, referral bonus program, and more. Pay reputed company $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 reputed company 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, reputed company time off, employee stock purchase reputed company, wellness programs, reputed company product discounts, and more. We reputed company your personal and reputed company reputed company with high reputed company Learning Programs featuring reputed company reputed company 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 reputed company. Valuing reputed company 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 reputed company selves to work, making an reputed company, and having reputed company 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 reputed company: Life At reputed company Outrageously Extraordinary reputed company Candidate reputed company Notice • For candidates based in reputed company reputed company, please refer to this Candidate reputed company Notice. • For candidates based in China, please refer to this Candidate reputed company Notice. • For candidates based in Vietnam, please refer to this Candidate reputed company Notice. We do not discriminate on the reputed company of race, religion, reputed company, national reputed company, sex, gender, gender reputed company, 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 tot his job Apply To this Job