Director of Regulatory Affairs

2 months ago

San Antonio, United States Extremity Care Full time
Job DescriptionJob DescriptionSalary: $116,288.

Purpose:

The Director of Regulatory Affairs is responsible for overseeing all regulatory matters, to include the regulatory framework, submissions, and functions to ensure that the quality management system and operational functions are compliant with FDA and state requirements, AATB Standards, ISO Standards, relevant international registration requirements, and other applicable regulations.


Duties & Responsibilities:

  • Create and implement regulatory strategies and solutions to ensure compliance with FDA and state requirements, AATB Standards, and other applicable regulations.
  • Support organizational strategic objectives.
  • Support facilitation of external audits and collaborate with Quality Assurance Management to generate audit responses and associated CAPAs.
  • Serve as primary regulatory contact for the organization to regulatory bodies and maintain effective relationships with regulatory agencies.
  • Perform and/or oversee regulatory review of procedures, marketing, and sales promotional label/labeling materials.
  • Perform and/or oversee regulatory review and approval for closure of deviations, nonconformances, complaints, CAPAs, SCARs.
  • Author/revise procedures according to FDA, AATB, and other regulations (as appropriate).
  • Oversee management of and/or support submissions of FDA/AATB reportable events.
  • Direct and oversee management of state license application submissions and renewals.
  • Oversee management of unique device identifiers (UDI) submissions and renewals.
  • Oversee management of regulatory submissions for TRG letters, Request for Designation (RFD), Pre-RFD, premarket notification/approvals, 510K, etc.
  • Lead, support, and/or oversee development and maintenance of design control, risk management, and other relevant procedures.
  • Lead, manage, and develop regulatory pathways for new product development projects, to include the identification of appropriate FDA product codes, predicate devices, and regulatory path requirements for new products.
  • Support development of qualification/validation protocols and verify compliance with regulatory requirements.
  • Perform and/or oversee regulatory review and approval of validation/verification/qualification plans, protocols, execution data, and summary assessments.
  • Provide regulatory guidance on case studies and clinical studies.
  • Provide regulatory support on research manuscripts and white papers.
  • Direct and oversee monitoring program for regulatory updates and internal compliance evaluation.
  • Monitor FDA activities, to include enforcement actions, warning letters, and 483s to analyze and report on company impact.
  • Collaborate with Product Development and Management to establish and support project timelines.
  • Provide regulatory oversight, support, and approval for new projects and products.
  • Integrate shared leadership and foster collaboration across multi-disciplinary teams for project groups.
  • Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, cGMP/CGTP, and other organizations policies and procedures.
  • File and maintain records in accordance with standard operating procedures.
  • Manage direct reports.
  • Establish and monitor objective annual goals for direct reports.
  • Conduct performance reviews and establish performance improvement plans as needed.
  • Recruit, interview, and select personnel for hire.
  • Travel domestically and internationally up to 10% to attend offsite meetings, conferences, and support business initiatives.
  • Attend/participate in offsite business meetings/conferences.
  • Report to work in-person and start job duties on time.
  • Complete required hours on assigned work shifts to complete assigned responsibilities and duties properly.
  • Attend all scheduled meetings and appointments
  • Perform other related duties as assigned.


Skills & Abilities:

  • Extensive knowledge of applicable government regulations.
  • Ability to inform and educate department heads on regulations and policies that require compliance.
  • Excellent attention to detail and organizational skills
  • Ability to multi-task
  • Effective and verbal communication skills.
  • Strong Leadership skills.
  • Ability to secure and maintain a favorable background investigation and clearance. 


Education & Experience:

  • Bachelor’s degree in biological science or related field required.
  • Master’s degree preferred.
  • At least 5 – 10 years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field) with progressive management responsibilities/experience.

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