Director of Regulatory Affairs

4 weeks ago

San Antonio, United States Extremity Care Full time

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.

  • Regulatory Affairs Director

    1 month ago

    San Diego, California, United States Codera Full time

    Job Title: Director, Regulatory AffairsCodera is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. We are seeking a highly skilled Director, Regulatory Affairs to support the development and execution of domestic and international regulatory strategy for Codera.Key...

  • Head of Regulatory Affairs

    1 month ago

    san diego, United States Trebla Talent Full time

    Role:Vice President or Senior Vice President of Regulatory AffairsSan Diego - HybridCompany Description:This is a pioneering cell therapy biotech focused on developing innovative immunotherapies for cancer treatment. They’ve had a fantastic 2024 following their IPO, and announcement of their autoimmune portfolio. Due to the promise of their technology,...

  • Head of Regulatory Affairs

    1 month ago

    san diego, United States Trebla Talent Full time

    Role:Vice President or Senior Vice President of Regulatory AffairsSan Diego - HybridCompany Description:This is a pioneering cell therapy biotech focused on developing innovative immunotherapies for cancer treatment. They’ve had a fantastic 2024 following their IPO, and announcement of their autoimmune portfolio. Due to the promise of their technology,...

  • Head of Regulatory Affairs

    1 month ago

    San Diego, United States Trebla Talent Full time

    Role:Vice President or Senior Vice President of Regulatory AffairsSan Diego - HybridCompany Description:This is a pioneering cell therapy biotech focused on developing innovative immunotherapies for cancer treatment. They’ve had a fantastic 2024 following their IPO, and announcement of their autoimmune portfolio. Due to the promise of their technology,...

  • Senior Director, Regulatory Affairs

    4 weeks ago

    South San Francisco, United States Structure Therapeutics Full time

    Structure Therapeutics develops life-changing medicines for patients using advanced structure-based and computational drug discovery technology. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that...

  • Regulatory Affairs Manager

    1 week ago

    San Diego, United States Surf Search Full time

    We are looking for a talented Regulatory Affairs Manager to join our client's team and play a crucial role in bringing new products to market. This role will be responsible for leading the regulatory strategy and managing submissions for new product launches for our client's cardiovascular medical device portfolio.This hands-on role requires a deep...

  • Quality and Regulatory Affairs Assistant

    4 weeks ago

    San Antonio, United States SA Scientific Full time

    Job DescriptionJob DescriptionWe are looking for a quality/regulatory affairs assistant to join our team. A good candidate would ideally have a bachelor's degrees in a life science, clinical research studies or engineering. Duties would include assisting with protocols and SOPs, coordinating and completing reports required by external agencies, assisting...

  • Vice President of Regulatory Affairs

    4 weeks ago

    San Diego, United States Dennis Partners Full time

    This clinical-stage biotech company is developing small molecule therapeutics for the treatment of devastating cancers and immune disorders. They are seeking a Vice President of Regulatory Affairs to develop and lead global regulatory strategies for their portfolio of programs and serve as the primary contact with health authorities. You will provide crucial...

  • Regulatory Investigator Lead

    12 hours ago

    San Diego, California, United States Department of Consumer Affairs Full time

    About the JobWe are seeking a highly skilled and experienced Regulatory Investigator to lead our investigative team in San Diego. As a key member of our Health Quality Investigation Unit, you will be responsible for overseeing complex investigations and ensuring that our department's regulatory requirements are met.Job SummaryThe successful candidate will...

  • Regulatory Affairs Consultant

    2 weeks ago

    San Diego, United States Calidi Biotherapeutics Full time

    The Regulatory Affairs Consultant will provide guidance to Calidi Biotherapeutics to ensure compliance with applicable regulations. This individual will be responsible for developing and implementing regulatory strategies, managing global regulatory submissions, and serving as the primary liaison with regulatory agencies. The consultant will oversee all...

  • Regulatory Affairs Consultant

    2 weeks ago

    san diego, United States Calidi Biotherapeutics Full time

    The Regulatory Affairs Consultant will provide guidance to Calidi Biotherapeutics to ensure compliance with applicable regulations. This individual will be responsible for developing and implementing regulatory strategies, managing global regulatory submissions, and serving as the primary liaison with regulatory agencies. The consultant will oversee all...

  • Regulatory Affairs Expert

    7 days ago

    San Jose, California, United States San Jose Water Company Full time

    About San Jose Water CompanySan Jose Water Company, a leading water utility in Silicon Valley, is seeking a highly skilled Regulatory Affairs Analyst to join our team. With over 150 years of experience, we pride ourselves on providing high-quality, life-sustaining water to over 1 million people.Compensation and BenefitsWe offer a competitive annual salary of...

  • Regulatory Affairs Specialist

    1 month ago

    San Francisco, California, United States Yoh Full time

    Regulatory Affairs SpecialistYoh is seeking a highly skilled Regulatory Affairs Specialist to join our team in St. Louis, Missouri. This individual will be responsible for planning and authoring pharmaceutical documents, ensuring compliance with regulatory requirements. The position offers a hybrid schedule and the opportunity to work with a growing...

  • VP Regulatory Affairs

    2 months ago

    San Francisco, United States EPM Scientific Full time

    Job DescriptionJob DescriptionTitle: Vice President Regulatory AffairsA rapidly growing biotech in CA is seeking a highly experienced Regulatory Affairs professional to join the team as the VP Regulatory Affairs. This company has seen massive growth over the past decade and just had an incredible data readout. They are excited to welcome on a new member of...

  • Associate Director, CMC Regulatory Affairs

    4 weeks ago

    South San Francisco, United States Allogene Therapeutics Full time

    About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T ) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline...

  • Regulatory Affairs Analyst

    6 months ago

    San Jose, United States San Jose Water Company Full time

    Job Title  Regulatory Affairs Analyst  | Requisition ID req607  Type of Employment Regular Full-Time Employee | Job Openings 1 Compensation Range - style="text-align:left;"> | Compensation Type Annual Salary Founded in 1866, San Jose Water Company is an investor owned water company headquartered in Silicon Valley. With a service...

  • Regulatory Affairs Assistant II

    1 month ago

    San Francisco, California, United States Innova Solutions Full time

    Job Title: Regulatory Affairs Assistant IIInnova Solutions is seeking a highly skilled Regulatory Affairs Assistant II to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the accuracy and completeness of regulatory data.Key Responsibilities:Perform data entry using Client RIM System to support key...

  • Vice President of Regulatory Affairs

    3 weeks ago

    San Diego, CA, United States Dennis Partners Full time

    This clinical-stage biotech company is developing small molecule therapeutics for the treatment of devastating cancers and immune disorders. They are seeking a Vice President of Regulatory Affairs to develop and lead global regulatory strategies for their portfolio of programs and serve as the primary contact with health authorities. You will provide crucial...

  • Senior Director Global Regulatory Affairs Strategy

    4 weeks ago

    San Francisco, California, United States Daiichi Sankyo, Inc. Full time

    Global Regulatory Affairs Strategy RoleDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally. As a key member of the Daiichi Sankyo team, you will be responsible for providing oversight and formulation of strategy for...

  • Regulatory Affairs Associate

    3 weeks ago

    South San Francisco, United States Alumis Full time

    Job DescriptionJob DescriptionAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an...