Sr. Regulatory Affairs Specialist

Sr. Regulatory Affairs SpecialistEstablished Medical Device company is looking to hire a Sr. Regulatory Affairs Specialist to join their growing team! Must bring a BS Degree and a minimum of 8 years of Regulatory Affairs experience.ResponsibilitiesDevelop regulatory plans, review design input/output documentation, and identify applicable standards and guidance documents.Perform regulatory assessments to determine the impact of design/process changes.Prepare and maintain regulatory submissions, including U.S. FDA 510(k) premarket notifications, Letters to File, pre-submissions, and Health Canada submissions.Provide regulatory guidance to product teams, develop strategies for the U.S. and Canadian markets, and influence global regulatory strategies.Coordinate with technical experts to provide additional data requested by regulatory agencies and respond to facilitate approvals.Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facilities.Collaborate with international counterparts to support global regulatory submissions, approvals, and rollout implementation.Lead regulatory documentation and author responses with minimal supervision.Advise on risk-based guidance to projects while ensuring cross-functional alignment.RequirementsMinimum of 8 years of regulatory affairs experience in a medical device company, with a strong understanding of US Medical Device regulations, Health Canada guidance, and EU MDR.Knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling.Ability to work efficiently in a fast-paced environment, managing multiple projects.Strong verbal and written communication skills, with the ability to translate technical documentation into effective regulatory submissions.Team-oriented, proactive, and capable of negotiating and influencing professionally.B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Pharmacy, or equivalent.RAPS RAC certification is a plus.System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. System One Holdings, LLC