Senior Regulatory Affairs Specialist

Job Summary: Under limited supervision, the Senior Regulatory Specialist is responsible for planning and executing critical and complex global regulatory projects necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements. Responsibilities include developing solutions to resolve complex regulatory issues and leading multifunctional teams in high-priority projects. Major Responsibilities:

Determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s). Communicate requirements of regulations to internal or external customers and recommend regulatory pathways, strategies, and solutions for specific products and scenarios. Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements. Complete and maintain varied regulatory filings by leading internal groups, collaborating with external groups, evaluating and providing direction on supporting technical information, writing appropriate summary documentation, providing direction on product/project changes, and responding to non-conformances and questions from regulators. Participate in the development, review, and substantiation of product labeling and claims. Manage individual projects by providing direction on diverse regulatory pathways, defining timelines for tasks and project teams, and recommending future actions and solutions. Assist in the review and development of processes related to regulatory activities of responsibility. Assist in the establishment and maintenance of department databases, logs, and files necessary for ensuring ongoing compliance. Actively participate in internal and external audits when applicable. Requirements:

Education - B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related. Work Experience - At least 4 years of experience in regulatory affairs in the medical device industry supporting domestic or international markets. Experience authoring and submitting regulatory submissions including 510(k)s and/or CE Technical Files. Experience preparing responses and communicating with regulatory agencies. Knowledge / Skills / Abilities - Understanding of the current Regulatory environment and demonstrating the ability to perform within. - Applied knowledge of FDA regulations and guidelines. - Ability to evaluate information to determine compliance with standards, laws, and regulations. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The Anticipated Salary Range For This Position $96,200.00 - $144,560.00 Annual Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

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