Principal Regulatory Affairs Specialist

2 weeks ago

Santa Clarita, United States huMannity Medtec Full time

At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at their best every day, and take your career to the next level, apply today


We truly understand the need for balance and, among other things and offer a 9/80 schedule with every other Friday off. That’s 26 long weekends a year


We are looking for an experienced and highly motivated Principal Regulatory Affairs Specialist to join our team and help us develop and demonstrate exciting technologies from ideation through clinical trials.


Position summary: The Principal Regulatory Affairs Specialist is responsible for participating on product development projects, evaluating document change orders for RA assessment, drafting regulatory submissions, and supporting regulatory related projects. The Principal Specialist will develop and implement regulatory strategies to obtain timely approvals for early feasibility studies. From creating regulatory submissions to providing critical input on cross-functional project teams, this role is an excellent opportunity to make a difference in people’s lives.


Main responsibilities:

  • Lead risk management activities, including the creation and maintenance of risk management documentation, such as FMEAs, hazard analysis, plans, reports, and trace matrices in accordance with ISO 14971 and cybersecurity requirements.
  • Participates in development teams and provides input to assure that regulatory requirements are incorporated in the product development process for Class III Medical Devices.
  • Create and submit regulatory submissions based on the regulatory strategy
  • Review and approve engineering change order documents
  • Review promotional material and labeling for regulatory compliance
  • Assist with negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval.
  • Works with R&D on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as review and approval of engineering protocols and reports.
  • Responsible for product packaging/labeling requirements and ensuring materials conform with applicable regulatory requirements.
  • Maintain regulatory documentation and registrations.
  • Drive improvements in quality system processes and procedures.


Education/Experience:

  • Bachelor’s degree and 8+ years of experience in the medical device industry, Class III preferred
  • Demonstrated command and knowledge of FDA and ISO medical device quality system requirements (21CFR820, ISO 13485, and ISO 14971) and audit programs (MDSAP)
  • Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
  • Experienced leading design assurance activities for new product development.
  • Critical Thinker, highly organized, efficient and self-motivated
  • Experience with SaMD and Digital Health apps
  • Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills

  • Principal Regulatory Affairs Specialist

    3 weeks ago

    Santa Clarita, United States huMannity Medtec Full time

    At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at...

  • Principal Regulatory Affairs Specialist

    1 week ago

    santa clarita, United States huMannity Medtec Full time

    At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at...

  • Principal Regulatory Affairs Specialist

    7 days ago

    santa clarita, United States huMannity Medtec Full time

    At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at...

  • Regulatory Affairs Specialist II

    7 days ago

    Santa Clarita, California, United States Boston Scientific Full time

    About Boston Scientific:Job Title: Regulatory Affairs Specialist II – NeuromodulationKey Responsibilities:Support regulatory submission activities for clinical investigations and product distributions globally.Ensure compliance with regulatory requirements worldwide.Key Accountabilities:Prepare submissions for worldwide product approvals.Support clinical...

  • Regulatory Affairs Specialist II

    3 days ago

    Santa Clarita, California, United States Boston Scientific Full time

    About the Role:We are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Boston Scientific. As a key member of our regulatory team, you will play a critical role in supporting the submission of regulatory documents to obtain and maintain approvals for conducting clinical investigations and commercially distributing products...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    Santa Clarita, United States BioTalent Full time

    *Hybrid on-site role in Valencia, CA - at least 1 day per week The Regulatory Affairs Specialist is responsible for supporting Regulatory activities which lead to, and maintain, regulatory compliance and approval for products globally. Duties and Responsibilities Perform gap analyses between new/revised regulations and standards and the Quality...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Santa Clarita, United States BioTalent Full time

    *Hybrid on-site role in Valencia, CA - at least 1 day per week The Regulatory Affairs Specialist is responsible for supporting Regulatory activities which lead to, and maintain, regulatory compliance and approval for products globally. Duties and Responsibilities Perform gap analyses between new/revised regulations and standards and the Quality...

  • Regulatory Affairs Specialist II

    3 months ago

    Santa Clarita, United States Boston Scientific Full time

    Recruiter: Spencer Gregory Hale Regulatory Affairs Specialist II – Neuromodulation About the role:Support the regulatory submission activities to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide. Participate in activities to ensure compliance with worldwide regulatory...

  • Regulatory Affairs Specialist II

    2 days ago

    Santa Clarita, United States Boston Scientific Full time

    Recruiter: Lydea Monahan Regulatory Affairs Specialist II – Neuromodulation About the role:Support the regulatory submission activities to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide. Participate in activities to ensure compliance with worldwide regulatory requirements. Your...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Santa Clarita, United States BioTalent Full time

    *Hybrid on-site role in Valencia, CA - at least 1 day per week The Regulatory Affairs Specialist is responsible for supporting Regulatory activities which lead to, and maintain, regulatory compliance and approval for products globally. Duties and Responsibilities Perform gap analyses between new/revised regulations and standards and the Quality Management...

  • Regulatory Affairs Specialist

    3 months ago

    Santa Clara, United States GForce Life Sciences Full time

    Regulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.Key...

  • Regulatory Affairs Specialist

    3 months ago

    Santa Clara, United States GForce Life Sciences Full time

    Regulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.Key...

  • Regulatory Affairs Specialist II

    15 hours ago

    Santa Clarita, California, United States Boston Scientific Full time

    About the Role:This is a critical position within Boston Scientific, responsible for supporting the regulatory submission activities to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide.Your Key Responsibilities:Support the preparation of submissions (e.g., PMA, PMA supplements, CE...

  • Lead Quality and Regulatory Affairs Specialist

    2 weeks ago

    Santa Clara, California, United States Intellectt Inc Full time

    Position: Senior Quality/Regulatory Affairs SpecialistCompany: Intellectt IncRole Overview:As a Senior Quality/Regulatory Affairs Specialist, you will play a pivotal role in ensuring compliance and quality within the regulatory affairs sector. Your expertise will be essential in supporting the regulatory affairs team from a quality assurance and compliance...

  • Head of CMC Regulatory Affairs

    7 days ago

    Santa Clara, California, United States Bayside Solutions Full time

    Director, CMC Regulatory Affairs - Strategic Leadership Opportunity at Bayside Solutions, Inc.Full-Time Role with Direct HireCompensation: Competitive salary packageLocation: Dynamic Redwood City, CA - Hybrid Work SettingPosition Overview:In the role of Director of CMC Regulatory Affairs, you will be instrumental in shaping and executing regulatory...

  • Head of CMC Regulatory Affairs

    2 weeks ago

    Santa Clara, California, United States Bayside Solutions Full time

    Chief, CMC Regulatory Affairs - Strategic Leadership Opportunity at Bayside Solutions, Inc.Position Type: Full-Time with Direct HireCompensation: Competitive salary offeredLocation: Hybrid Work Environment in Redwood City, CAPosition Overview:In the role of Chief of CMC Regulatory Affairs, you will be instrumental in formulating and executing regulatory...

  • Head of CMC Regulatory Affairs

    7 days ago

    Santa Clara, California, United States Bayside Solutions Full time

    Director, CMC Regulatory Affairs - Strategic Leadership Opportunity at Bayside Solutions, Inc.Full-Time Position with Direct HireCompensation: Competitive salaryLocation: Flexible Hybrid Work EnvironmentPosition Overview:In the role of Director of CMC Regulatory Affairs, you will be instrumental in shaping and executing regulatory frameworks that facilitate...

  • Head of CMC Regulatory Affairs

    7 days ago

    Santa Clara, California, United States Bayside Solutions Full time

    Director, CMC Regulatory Affairs - Key Leadership Position at Bayside Solutions, Inc.Full-Time Role with Direct Hire OpportunityCompensation: Competitive salary packageLocation: Dynamic Redwood City, CA - Hybrid Work ModelPosition Overview:In the role of Director of CMC Regulatory Affairs, you will be instrumental in shaping and executing regulatory...

  • Regulatory Affairs Senior Specialist

    2 weeks ago

    Santa Clara, California, United States Abbott Full time

    About Abbott:Abbott is a prominent global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their journey. Our extensive range of transformative technologies encompasses various healthcare sectors, including diagnostics, medical devices, nutritionals, and branded generic medications. With a workforce of...

  • Lead Specialist in Regulatory Affairs

    2 weeks ago

    Santa Clara, California, United States Abbott Full time

    Lead Specialist in Regulatory AffairsAbbott stands as a prominent figure in the global healthcare sector, dedicated to enhancing the quality of life for individuals at every stage. Our extensive range of transformative technologies encompasses various healthcare domains, featuring top-tier businesses and products in diagnostics, medical devices,...