Lead Regulatory Affairs Expert

2 weeks ago

San Diego, California, United States Genalyte Full time
Position Overview

Genalyte, Inc., a pioneer in innovative diagnostic solutions, is on the lookout for a highly experienced and driven Senior Regulatory Affairs Specialist to enhance our dynamic workforce. In this crucial position, you will utilize your regulatory expertise to navigate intricate compliance landscapes, ensuring our revolutionary products adhere to all necessary regulations and efficiently reach the market. If you are dedicated to improving healthcare through state-of-the-art technology and excel in a collaborative setting, we encourage you to contribute to our mission of transforming diagnostic testing and enhancing patient care.

Key Responsibilities
  • Develop, review, and enhance technical documentation for regulatory submissions, ensuring conformity with relevant guidelines.
  • Coordinate and oversee Q-submissions to facilitate timely FDA feedback.
  • Lead the preparation and submission of 510(k), PMA, and CE applications.
  • Manage e-STAR regulatory submission criteria to meet established standards.
  • Maintain detailed regulatory files, including 510(k)s, PMAs, Q-Submissions, and CE dossiers for the European Union.
  • Design and manage labeling documents for regulatory submissions.
  • Collaborate with various departments to convey regulatory requirements and monitor submission deliverables according to project schedules.
  • Provide strategic regulatory insights and analysis to support the team.
  • Track and ensure the accuracy and currency of regulatory registrations, certifications, and licenses.
  • Stay informed on regulations and guidance documents to maintain ongoing compliance.
  • Assist with external regulatory agency audits, providing regulatory insights to mitigate non-compliance risks.
  • Organize and maintain all regulatory-related documentation with precision.
  • Comply with the company's Quality Management System (QMS).
  • Perform additional responsibilities as assigned, contributing to the overall success of the team.
Qualifications
  • A minimum of a Bachelor's degree in a scientific discipline or a related field, along with 5-7 years of experience in IVD regulatory affairs or a similar area.
  • Certification in regulatory affairs is advantageous.
  • Strong comprehension of regulations coupled with excellent analytical and problem-solving abilities.
  • Exceptional written and verbal communication skills, with the capacity to listen, articulate, and advocate effectively.
  • Strong prioritization skills, adaptability, and the ability to manage multiple projects concurrently while meeting deadlines.
  • Ability to communicate effectively with colleagues across various departments.
  • Proficient in Microsoft Office Suite, including Word, Excel, and PowerPoint.
  • Strong organizational skills and attention to detail, with the capability to handle numerous projects under tight timelines.
Why Choose Genalyte?

At Genalyte, we prioritize the well-being and success of our employees. As a valued member of our organization, you will benefit from a comprehensive benefits package, including a competitive salary, health, dental, and vision insurance, as well as flexible paid time off. Additionally, we offer stock ownership and equity participation, allowing you to share in the success and growth of the company. Join us in shaping the future of healthcare while building a fulfilling career.

  • Lead Regulatory Affairs Expert

    2 weeks ago

    San Diego, California, United States Genalyte Full time

    Senior Regulatory Affairs SpecialistGenalyte, Inc., a frontrunner in cutting-edge diagnostic solutions, is seeking a highly qualified and driven Senior Regulatory Affairs Specialist to become part of their innovative team. In this position, you will be tasked with navigating intricate regulatory frameworks to guarantee adherence to all standards and...

  • Lead Regulatory Affairs Expert

    2 weeks ago

    San Diego, California, United States Genalyte Full time

    Position OverviewGenalyte, Inc., a pioneer in innovative diagnostic solutions, is in search of a highly experienced and driven Senior Regulatory Affairs Specialist to enhance our dynamic workforce. In this crucial position, you will utilize your knowledge to navigate intricate regulatory frameworks, ensuring our revolutionary products adhere to all...

  • Lead Regulatory Affairs Expert

    1 week ago

    San Diego, California, United States Genalyte Full time

    Position OverviewGenalyte, Inc., a frontrunner in pioneering diagnostic technologies, is in search of a proficient and driven Senior Regulatory Affairs Specialist to enhance our innovative team. In this crucial position, you will utilize your regulatory expertise to navigate intricate compliance frameworks, ensuring our revolutionary products adhere to all...

  • Lead Specialist in Regulatory Affairs

    2 weeks ago

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

    Key Responsibilities: Oversee and support regulatory policy initiatives within the Regulatory Science and Policy team. Demonstrate proficiency in navigating a matrix organization and managing uncertainty to facilitate decision-making across various teams. Collaborate with regulatory leads to provide cross-functional support on both strategic and...

  • Lead Regulatory Affairs Expert for IVD Product Lifecycle

    2 weeks ago

    San Diego, California, United States Hologic Full time

    Position Overview:We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our Diagnostics Regulatory Affairs team. This role is pivotal in overseeing the regulatory processes associated with in vitro diagnostic (IVD) products throughout their lifecycle, including new product development and ongoing market compliance.Key...

  • Lead Specialist in Regulatory Affairs

    1 week ago

    San Diego, California, United States INVIVOSCRIBE INC Full time

    Join Our TeamInvivoscribe is a premier organization committed to Precision Diagnostics aimed at improving lives. With over 25 years of expertise, we have been leaders in the global standardization of testing and providing access to innovative cancer therapies.Located in the dynamic region of San Diego, California, our international reach enables us to...

  • Regulatory Affairs and Compliance Lead

    5 days ago

    San Diego, California, United States ORIC Pharmaceuticals, Inc. Full time

    Job SummaryORIC Pharmaceuticals, Inc. is seeking a highly motivated and experienced Director/Associate Director to lead our Regulatory Affairs and Compliance team. As a key member of our organization, you will be responsible for ensuring compliance with global regulatory requirements and developing strategies to support our clinical development programs.Key...

  • Regulatory Affairs Director

    6 days ago

    San Diego, California, United States Modular Medical Inc Full time

    Job Description**Job Title:** Director of Regulatory Affairs**Job Category:** Exempt**Department:** R&D**Direct Report:** N/A**Location:** N/A**Travel Required:** N/A**Salary Range:** N/A**Position Type:** Full-time/OnsiteJob SummaryModular Medical Inc is seeking a highly experienced Director of Regulatory Affairs to lead our regulatory strategy and ensure...

  • Regulatory Affairs Director

    2 days ago

    San Diego, California, United States Tbwa ChiatDay Inc Full time

    Job SummaryWe are seeking a highly experienced Regulatory Affairs Director or Senior Regulatory Affairs Director to join our team at Kura Oncology. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with governing laws, regulations, and internal policies and procedures.Key ResponsibilitiesEnsure U.S....

  • Regulatory Affairs Leader

    1 week ago

    San Diego, California, United States Radionetics Oncology Full time

    About Radionetics OncologyRadionetics Oncology is a clinical-stage biotechnology company dedicated to the discovery and development of innovative radiopharmaceuticals for the treatment of various oncology indications. With a strong focus on novel radiotherapeutics, the company is poised to capitalize on the growing demand for effective cancer...

  • Regulatory Affairs Manager

    2 months ago

    San Diego, California, United States Surf Search Full time

    Join Our Team as a Regulatory Affairs ManagerWe are seeking a skilled Regulatory Affairs Manager to become part of our client's team and have a significant role in introducing new products to the market. As the Regulatory Affairs Manager, you will be responsible for leading the regulatory strategy and overseeing submissions for new product releases within...

  • Regulatory Affairs Senior Manager

    1 week ago

    San Diego, California, United States Contineum Therapeutics Full time

    Position Overview:Reporting directly to the Senior Vice President of Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will spearhead and engage in regulatory initiatives related to IND/CTA preparations and ongoing maintenance to facilitate both new and existing development programs. This position demands a proactive,...

  • Regulatory Affairs Senior Manager

    2 weeks ago

    San Diego, California, United States Contineum Therapeutics Full time

    Position Overview:Reporting to the Senior Vice President of Regulatory Affairs, the Regulatory Affairs Senior Manager or Associate Director will spearhead and engage in regulatory initiatives related to IND/CTA preparation and ongoing maintenance to facilitate both new and existing development programs. This position necessitates a proactive,...

  • Senior Regulatory Affairs Consultant

    2 weeks ago

    San Diego, California, United States Katalyst HealthCares & Life Sciences Full time

    Position Title: Regulatory Affairs SpecialistCompany: Katalyst HealthCares & Life SciencesEmployment Type: ContractDuration: 12 monthsDepartment: Regulatory AffairsQualifications: Bachelor’s or Master’s degree in a relevant Scientific Discipline At least 7 years of experience in the pharmaceutical sector Minimum of 5 years of experience in CMC regulatory...

  • Head of Regulatory Affairs Strategy

    1 week ago

    San Diego, California, United States Cypress HCM Full time

    Exciting Opportunity in Regulatory AffairsAre you an experienced professional with a strong background in global regulatory management and project execution? As a pivotal member of Cypress HCM, you will be instrumental in advancing our objectives within the pharmaceutical sector. In the role of Regulatory Affairs Director, you will be responsible for...

  • Regulatory Affairs Specialist

    3 days ago

    San Diego, California, United States Therapeutics Inc. Full time

    Job DescriptionCompany OverviewTherapeutics Inc. is a leading full-service dermatology Contract Research Organization (CRO) that has been serving the industry for over 25 years. We take pride in our company culture, which values collaboration, diversity, and dedicated talent. Our team is passionate about delivering high-quality work and making a difference...

  • Head of Regulatory Affairs Strategy

    1 week ago

    San Diego, California, United States Cypress HCM Full time

    Strategic Role in Regulatory AffairsAre you an experienced professional with a strong interest in international regulatory management and project oversight? As a key player in the pharmaceutical sector, you will assume a vital position in steering the development of innovative products while ensuring adherence to local and global regulations.Key...

  • Regulatory Affairs Director

    1 week ago

    San Diego, California, United States Codera Full time

    Job DescriptionOverviewCodera, a leading life sciences-focused investment company, is seeking a highly skilled Regulatory Affairs Director to support the development and execution of domestic and international regulatory strategy.Key ResponsibilitiesRegulatory Strategy Development: Provide strategic advice and support the development and execution of...

  • Regulatory Affairs Director

    1 week ago

    San Diego, California, United States Codera Full time

    Job DescriptionOverviewCodera, a leading life sciences-focused investment company, is seeking a highly skilled Regulatory Affairs Director to support the development and execution of domestic and international regulatory strategy.Key ResponsibilitiesRegulatory Strategy Development: Provide strategic advice and support the development and execution of...

  • Head of Regulatory Affairs

    1 week ago

    San Diego, California, United States Travere Therapeutics Full time

    Director of Global Regulatory AffairsDepartment: RegulatoryLocation: San DiegoJoin a global team dedicated to transforming the lives of individuals affected by rare diseases.At Travere Therapeutics, we understand that our outstanding workforce is crucial to our achievements. We are a committed group focused on addressing the specific needs of patients with...