Job Description

REGULATORY AFFAIRS SPECIALIST

Job Overview:

We are seeking a Regulatory Affairs Specialist specializing in 510(k) Class II filings to lead global device and market registrations and ensure regulatory compliance. This role involves providing product labeling details, technical and legalized documents related to medical device registration and commercialization. The Regulatory Affairs Specialist will also collaborate with regulatory staff across business units and countries to understand global registration and market clearance requirements.

Key Responsibilities:

• Interpret federal, state, and international regulations as they apply to company products, processes, and procedures.
• Advise on the impact of regulations, devise compliance strategies, and act as a liaison with regulatory bodies.
• Investigate and resolve compliance issues, questions, and complaints.
• Audit and evaluate current policies, procedures, and documentation to ensure regulatory compliance.
• Determine the need for and prepare regulatory submissions, negotiate agency inquiries, and secure market clearance, approvals, licenses, and renewals (e.g., CFGs, CoOs, CE renewals) for company products.
• Formulate or implement regulatory affairs policies and procedures to maintain or enhance compliance.
• Train staff in regulatory policies and procedures.
• Monitor emerging industry regulations to assess their impact on organizational processes.
• Provide regulatory guidance to departments or project teams regarding product design, development, evaluation, and marketing.
• Coordinate internal discoveries and depositions with the Legal Department.

Qualifications & Requirements:

• Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.
• Proven experience in regulatory affairs and quality management, particularly with 510(k) Class II filings.
• Strong knowledge of global medical device regulations and market clearance processes.
• Experience in handling regulatory submissions, compliance audits, and quality assurance procedures.
• Ability to communicate effectively with regulatory agencies, internal teams, and external partners.
• Ability to track and analyze emerging trends and regulatory changes affecting the medical device industry.

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