Job Summary

This Associate Director, Regulatory Affairs, will work on-site. As a manager, the function of an Associate Director, Regulatory Affairs, is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual will develop and supervise regulatory professionals. The individual has department level influence and is generally recognized as an expert resource both within the company and externally. The individual may comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information. The individual will ensure that data is identified, obtained and effectively presented for the registration of products worldwide.

Job Responsibilities

• Set strategy and direct preparation of submissions for products to regulatory agencies, and interface with agencies in order to obtain timely approval to produce and market new products.
• Provide guidance on regulatory requirements and strategies for product development project teams.
• Provide regulatory input for capital equipment and software, including knowledge of IEC standards (e.g., IEC 60601-1).
• Provide regulatory input on cybersecurity and Artificial Intelligence (AI).
• Maintain expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicate such knowledge to all internal stakeholders.
• Consult with and provide advice to senior management of the Company on strategies and plans for regulatory product approvals.
• Direct staff in implementing regulatory strategy and preparing regulatory submissions.
• Remain current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and train staff regarding changing regulations that affect regulatory submissions.
• Maintain knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.
• Resolve and/or facilitate resolution of problems including identifying causes to prevent re-occurrence.
• Perform related functions and responsibilities, on occasion, as assigned.
• Hire and retain a diverse, highly qualified staff and provide ongoing performance feedback.
• Maintain a safe and professional work environment.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communication.

Required Qualifications

• Bachelor’s Degree or an equivalent combination of education and work experience.
• 5-7 years of experience in a regulated industry (e.g., medical products, nutritionals).
• 5-7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
  

Preferred Qualifications

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
• M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• Previous experience with 510k / PMA submissions.
• Experience working with hardware/ software devices.
• Familiarity with Predetermined Change Control Plans (PCCPs).
• Experience with Medical Devices.