Staff Regulatory Affairs Specialist

2 weeks ago

San Diego, United States BioTalent Full time

Staff Regulatory Affairs Specialist responsibilities will include: development, execution and management of submissions, development and review of procedures and systems design to support regulatory processes, and address global regulatory requirements and business objectives.


Key Responsibilities

• Define regulatory strategy for complex Class II products.

• Prepare regulatory submissions (e.g., to FDA, Notified Body) for complex HW/SW based electromechanical devices, as well as conduct regulatory change assessments.

• Review, approve, and author documents required for regulatory submissions to product.

• Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory changes to partners.

• Proactively lead regulatory efforts required to align with new regulations and requirements, i.e., EU MDR, MDSAP.

• Review changes and related documentation to assure collection of appropriate data for regulatory submissions and regulatory compliance.

• Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.

• Work cross-functionally across multiple departments to communicate change impact.

• Remain current on standards and regulations affecting products and communicate and incorporate required changes.

• Support regulatory compliance activities, such as audits, CAPAs etc., as needed.

• Identify ways to improve the efficiency of current work process and implement them.

• Performs other duties and assignments as required.


Minimum Qualifications

• Bachelor’s degree required, Master’s degree in life sciences field preferred.

• 5+ years of strong Regulatory Affairs experience in the medical device industry.

• Proven prior experience required owning and managing the end-to-end process of authoring, submitting and obtaining regulatory approvals/clearances (510(k)s), including addressing and responding to deficiencies from regulatory agencies.

• Working knowledge of medical device stand-alone software, device interoperability and IEC 62304 software development lifecycle.

• Sound understanding of design control processes, FDA, and global regulations and standards.

• Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information.

• Excellent interpersonal, communication and analytical skills.

• Knowledge of software and medical device design regulations and standards.

  • Staff Regulatory Affairs Specialist

    2 weeks ago

    San Diego, United States BioTalent Full time

    Staff Regulatory Affairs Specialist responsibilities will include: development, execution and management of submissions, development and review of procedures and systems design to support regulatory processes, and address global regulatory requirements and business objectives. Key Responsibilities Define regulatory strategy for complex Class II products. ...

  • Regulatory Affairs Specialist

    7 days ago

    San Diego, United States Cypress Human Capital Management, LLC Full time

    Regulatory Affairs Specialist The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...

  • Regulatory Affairs Specialist

    6 days ago

    San Diego, United States Genalyte Full time

    Here at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician’s office. We have a great opportunity for a Regulatory Affairs Specialist to join our team! **ABOUT THE ROLE** The Regulatory...

  • Regulatory Affairs Specialist

    4 days ago

    San Diego, United States Cypress HCM Full time

    Regulatory Affairs Specialist The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...

  • Regulatory Affairs Specialist

    4 weeks ago

    San Diego, United States Cypress HCM Full time

    Regulatory Affairs SpecialistThe Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...

  • Regulatory Affairs Specialist

    3 weeks ago

    San Diego, United States Cypress HCM Full time

    Regulatory Affairs SpecialistThe Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...

  • Regulatory Affairs Specialist

    3 days ago

    San Diego, United States Aequor Technologies Full time

    US Regulatory Affairs Lead ------------------------------------------------------------------------------------------------- SCOPE OF RESPONSIBILITIES: " He/She will be responsible for representing regulatory function to approve promotional material " He/She will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision...

  • Regulatory Affairs Specialist

    3 weeks ago

    San Francisco, California, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities:Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products\' registration.Participate on product development teams, providing regulatory strategies, timelines, and direction. Reviews and approves technical...

  • Vice President, Regulatory Affairs

    7 days ago

    San Diego, United States Device Search Group Defunct Full time

    We are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background in cell therapy with experience in early development regulatory affairs (pre-IND...

  • Vice President, Regulatory Affairs

    1 day ago

    San Diego, United States Device Search Group Full time

    We are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background in cell therapy with experience in early development regulatory affairs (pre-IND...

  • Vice President, Regulatory Affairs

    1 week ago

    San Diego, United States Device Search Group Full time

    We are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background in cell therapy with experience in early development regulatory affairs (pre-IND...

  • Regulatory Affairs Director

    3 weeks ago

    San Francisco, United States BioLink 360 Full time

    Company Location: Bay Area Comp: 150K-220K Position Reports to: VP of Regulatory and Quality Director of Regulatory Affairs -San Francisco We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help develop &...

  • Senior Regulatory Affairs Specialist-Remote Based-West Coast

    3 weeks ago

    San Francisco, United States BioLink 360 Full time

    Senior Regulatory Affairs Specialist-Remote Based-West Coast Description Reports to: Global Regulatory Affairs Director Salary Range: 140-170K Location: Remote Based Travel: Occasional travel to West Coast, Must reside in Pacific or Mountain time zone This Senior Regulatory Affairs Specialist will have an opportunity to work on new to market technology that...

  • Executive Director, Regulatory Affairs

    7 days ago

    San Diego, United States Partnology Full time

    An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Executive Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities essential for...

  • Director, Regulatory Affairs

    6 days ago

    South San Francisco, United States Maze Therapeutics Full time

    The Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you will...

  • Regulatory Affairs CMC Associate

    1 week ago

    San Mateo, United States Fladger Assoc. Inc. Full time

    Job DescriptionJob DescriptionFoster City, CAContract Duration: 6-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLYProvide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology,...

  • Executive Director, Regulatory Affairs

    5 days ago

    San Diego, United States Partnology Full time

    An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Executive Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities essential for...

  • Executive Director, Regulatory Affairs

    4 weeks ago

    San Diego, United States Partnology Full time

    An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Executive Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities essential for...

  • Executive Director, Regulatory Affairs

    3 weeks ago

    San Diego, United States Partnology Full time

    An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Executive Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities essential for...

  • Director, Regulatory Affairs

    5 days ago

    South San Francisco, United States Maze Therapeutics Full time

    Job DescriptionJob DescriptionThe Position:Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global...