Regulatory Specialist II

Company

Diazyme

Job Summary

Diazyme, an affiliate of General Atomics, is a cGMP and ISO 13485 certified medical device manufacturer. Diazyme uses its proprietary enzyme technologies to develop diagnostic reagents which can be used on most automated chemistry analyzers in user-friendly formats. Their products include test kits for diagnosis of cardiovascular disease, liver disease, cancer markers, renal disease, diabetes, and electrolytes.

Under general supervision with intermittent review, this position is responsible for ensuring the organization’s products, services, and activities comply with applicable laws, regulations, and internal standards. Assists in implementing regulatory strategies, procedures, and controls for products and/or business activities. Responsibilities may include preparing, formatting, and maintaining paper and electronic in vitro diagnostic (IVD) medical devices regulatory submissions for FDA 510k and CLIA categorizations, EU IVDR, Health Canada, in accordance with document management standards and regulatory requirements, and ensuring documentation is accurate, complete, and aligned with applicable requirements and internal standards.

DUTIES & RESPONSIBILITIES:

• Supports FDA 21 CFR Part 820, Health Canada SOR/98-282 and EU IVDR 2017/746 IVD medical device regulatory compliance activities and programs, including assisting with the planning, implementation, and monitoring of processes, systems, and controls to meet applicable regulatory requirements and internal standards.
• Assists in the development and execution of regulatory strategies for new and existing products, services, and business activities under the guidance of more experienced staff.
• Helps review and maintain regulatory policies, procedures, and related documentation; identifies issues, recommends improvements, and supports audits, inspections, and continuous improvement efforts.
• Works closely with internal stakeholders, providing information and some guidance on submission requirements, timelines, and standards.
• Prepares draft responses and supporting materials for regulatory inquiries and inspections and may participate in interactions with regulatory agencies and external parties.
• Maintains strict confidentiality of sensitive information.
• Responsible for observing all laws, regulations and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to maintain a productive and safe working environment in accordance with established operating procedures and practices.
• Performs other duties as assigned.

We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply.

Travel Percentage Required

0% - 25%

Pay Range Low

68,770

Clearance Required?

No

Pay Range High

116,193

Job Qualifications

• Typically requires a Bachelor's degree in Business Administration or a related discipline and three or more years of progressive experience in a regulated environment. May substitute equivalent professional experience in lieu of education
• Must demonstrate a general understanding and application of IVD medical device regulatory compliance pre-market and post-market principles, theories, and concepts as well as the practices, techniques, and standards; and leadership skills including organizing, scheduling, and coordinating work assignments to meet milestones or established completion dates.
• Must be customer focused and possess: (1) the ability to develop solutions to a variety of problems of moderate scope and complexity; (2) excellent verbal and written communications and presentations skills to accurately document and report findings to a variety of audiences; (3) excellent interpersonal skills to influence and guide employees, managers and external parties; (4) the ability to maintain the confidentiality of sensitive information; and, (5) excellent computer skills.
• Ability to work independently or in a team environment is essential as is the ability to work extended hours and travel as required.

US Citizenship Required?

No