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Regulatory Affairs Specialist

  • Specialty:

    • City:

    • State:

    • 03584
  • Assignment Type:

    Direct Hire
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Regulatory Affairs Manager 


Oversees the regulatory process for products requiring governmental approval, including filing necessary applications and handling all government interactions. Ensures compliance with regulations and standard operating procedures (SOP) to minimize product liability and add business value.


  • Report information on regulatory trends and concerns to the leadership team
  • Work closely with the quality on regulatory responsibility
  • Complete regulatory submissions to governmental agencies
  • Advise on new product regulatory and compliance risk
  • Integrate customer quality systems with quality systems
  • Host facility audits; serve as primary contact for auditors (regulatory body, 3rd party, customers, etc)
  • Represent Regulatory Affairs on R&D product development
  • Serve as Company representative with regulators, trade associations, corporate personnel, legal resources and external customers
  • Review reports and documentation to assure compliance with regulations
  • Interpret laws, regulations, and guidance to be applied as appropriate 
  • Support introductory and recurrent training for all personnel in regulatory affairs
  • Work as liaison with regulatory attorney for guidance to ensure compliance
  • Complete customer questionnaires as they pertain to regulatory
  • Manage Internal Audit Program


Strong interpersonal skills with the ability to influence others in a positive and effective manner. Ability to work well in both an individual and group setting. Critical thinking using logic and reasoning to identify the strengths and weaknesses of alternative solutions to problems.

Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.

Experience in FDA regulated environment with strong knowledge of 21-CFR 210, 211, 111 required.


Bachelor's degree (B. A.) from four-year college or university

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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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