Regulatory Affairs Lead
2 weeks ago
The Staff Regulatory Affairs Specialist plays a pivotal role in ensuring the company's products meet global regulatory requirements. This key position involves product registrations, acting as the company representative with regulatory authorities, and representing Regulatory Affairs on product development teams.
Duties and Responsibilities- Design Control: Provide strategic guidance on global regulatory requirements to support product marketing authorizations, review product design and change documentation, and perform regulatory assessments.
- Regulatory Projects: Independently lead multiple long-term projects, interact with manager as required, and model effective team dynamics behavior.
- Marketing Authorizations: Assess and document regulatory marketing requirements for global markets, schedule milestones, generate supporting documentation, and provide deliverables for assigned regulatory applications and renewals.
- Regulatory Intelligence: Acquire and maintain current knowledge of applicable regulatory requirements and scientific issues in marketed geographies, monitor and analyze the development of new and emerging regulations, and coordinate evaluation of new and emerging standards with Subject Matter Experts.
- Bachelor's degree in a life science, engineering, or equivalent required, advanced degree preferred.
- Minimum 6 years of experience in Regulatory Affairs, of which a minimum of 4 years must be in IVD Regulatory Affairs.
- Regulatory Affairs Certification preferred, experience in regulatory submissions including 510(k) and IVDR technical documentation required.
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Regulatory Affairs Lead
2 weeks ago
San Diego, California, United States Real Staffing Full timeA leading medical device company is seeking a highly skilled Regulatory Affairs Lead to join their team. As a key member of the organization, you will be responsible for leading the original PMA submission and assisting with additional submissions and day-to-day regulatory functions.Key Responsibilities:Lead real-time Original PMA submissionAssist with...
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Regulatory Affairs Lead
1 week ago
San Diego, California, United States Aequor Technologies Full timeCompany Overview: Aequor Technologies is a leading provider of innovative solutions for the personal care industry. Our team is dedicated to delivering high-quality products that meet the highest standards of regulatory compliance.Job Description : We are seeking an experienced Regulatory Affairs Specialist to join our team. As a Regulatory Affairs...
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Regulatory Affairs Lead
2 weeks ago
San Diego, California, United States Sharp HealthCare Full timeJob DescriptionWe are seeking a detail-oriented Regulatory Affairs Lead to join our regulatory department. The ideal candidate will be responsible for ensuring Sharp HealthCare remains compliant with all federal, state, and local regulations.The successful candidate will work closely with hospital administration, clinical departments, and external regulatory...
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Regulatory Affairs Specialist Lead
1 week ago
San Diego, California, United States Tandem Full timeGROW WITH US: Tandem Diabetes Care empowers individuals living with diabetes, their loved ones, and healthcare providers to innovate and thrive. As a Regulatory Affairs Specialist II, you will play a critical role in shaping our company's positively different experience.About the RoleThe Sr. Regulatory Affairs Specialist II is responsible for developing...
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Global Regulatory Affairs Lead
2 weeks ago
San Diego, California, United States BioTalent Full timeAbout BioTalent:BioTalent is a leading player in the medical equipment manufacturing industry, committed to delivering innovative solutions that improve patient care.Job Description:We are seeking an experienced Regulatory Affairs Manager to join our team. The successful candidate will lead a team of technical staff in developing regulatory plans for...
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Sustainability and Regulatory Affairs Lead
1 week ago
San Diego, California, United States Clearway Energy, Inc. Full timeAs a Sustainability and Regulatory Affairs Lead at Clearway Energy, Inc., you will be responsible for driving our sustainability and regulatory affairs strategy forward.About the RoleThis is an exciting opportunity to join our team and contribute to our mission of delivering clean energy solutions.Key ResponsibilitiesDevelop and implement sustainability and...
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Regulatory Affairs Specialist Lead
1 week ago
San Diego, California, United States BioTalent Full time**Job Overview:**BioTalent is seeking a highly experienced and skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the compliance of our products with global regulations.**Responsibilities:**Regulatory Compliance: Ensure that all product registrations are compliant...
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Regulatory Affairs Strategic Lead
3 days ago
San Diego, California, United States Jobleads-US Full timeFate Therapeutics is seeking an experienced Executive Director or Senior Director to lead the strategic planning and execution of clinical regulatory activities. This role will oversee cross-functional teams and interact with regulatory agencies such as the FDA and EMA.Responsibilities:Develop and implement clinical regulatory strategies for global filings,...
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Regulatory Affairs Lead
2 weeks ago
San Diego, California, United States Real Staffing Full timeA leading Class II/III Medical Device client of Real Staffing is looking to bring on a senior regulatory affairs specialist to join their team. This opportunity will allow you to lead a real-time Original PMA submission and contribute to additional submissions and other day-to-day regulatory functions for a thriving medical device company.Key...
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Strategic Regulatory Affairs Lead
1 week ago
San Diego, California, United States Jobleads-US Full timeAbout the Role: We are seeking an experienced Strategic Regulatory Affairs Lead to join our team at Jobleads-US. As a key member of our regulatory department, you will be responsible for establishing and executing strategic plans for regulatory submissions across various product lines.About the Company: Jobleads-US is a leading provider of innovative...
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Regulatory Affairs Specialist Lead
1 week ago
San Diego, California, United States BioTalent Full timeJob OverviewBioTalent is seeking an experienced Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will be responsible for ensuring compliance with regulatory requirements for our in vitro diagnostic products.About the RoleThis is a dynamic opportunity for a highly motivated and organized individual who can...
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Regulatory Affairs Leader
2 weeks ago
San Diego, California, United States Iambic Therapeutics Full timeJob DescriptionThe Executive Director, Head of Regulatory Affairs will oversee all regulatory activities related to the development of innovative small molecules for cancer treatment.Key ResponsibilitiesLead regulatory affairs activities including team management and strategic planning.Develop and implement regulatory strategies aligning with business...
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Head of Regulatory Affairs
1 week ago
San Diego, California, United States Ryvyl Inc Full timeWe are seeking an accomplished professional to lead our Regulatory Affairs team at Ryvyl Inc. The ideal candidate will have a strong background in compliance, risk management, and regulatory affairs.Responsibilities:Develop and implement strategic compliance plans to ensure regulatory compliance.Collaborate with cross-functional teams to integrate compliance...
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Regulatory Affairs Manager
4 weeks ago
San Diego, California, United States BioPhase Full timeRegulatory Affairs ManagerLocation: San Diego, CA (Onsite)Salary Range: $145,000 - $165,000Job SummaryBioPhase is seeking a Regulatory Affairs Manager to lead regulatory strategy and compliance for in vitro diagnostic (IVD) products. This role oversees regulatory submissions, market authorizations, and agency communications, ensuring compliance with FDA, EU...
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Regulatory Affairs Manager
2 weeks ago
San Diego, California, United States BioPhase Full timeRegulatory Affairs ManagerLocation: San Diego, CA (Onsite)Salary Range: $145,000 - $165,000Job SummaryBioPhase is seeking a Regulatory Affairs Manager to lead regulatory strategy and compliance for in vitro diagnostic (IVD) products. This role oversees regulatory submissions, market authorizations, and agency communications, ensuring compliance with FDA, EU...
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Regulatory Affairs Manager
2 weeks ago
San Diego, California, United States BioPhase Solutions Full timeJob Description Job Description Regulatory Affairs Manager Location: San Diego, CA (Onsite)Salary Range: $145,000 - $165,000 Job Summary BioPhase is seeking a Regulatory Affairs Manager to lead regulatory strategy and compliance for in vitro diagnostic (IVD) products. This role oversees regulatory submissions, market authorizations, and agency...
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Regulatory Affairs Expert
5 days ago
San Diego, California, United States Aequor Technologies Full timeAequor Technologies seeks a highly skilled Regulatory Affairs Expert to lead our regulatory efforts. As a key member of our team, you will be responsible for representing the company's regulatory function to approve promotional materials.The ideal candidate will have excellent communication skills and be able to navigate ambiguity to drive decision-making...
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Regulatory Affairs Expert
1 week ago
San Diego, California, United States BD (Becton, Dickinson and Company) Full timeJob OverviewBecton, Dickinson and Company is a leading medical technology company that is committed to advancing the world of health. We are seeking a highly skilled Regulatory Affairs Expert to join our team in San Diego, CA.The ideal candidate will have a strong background in regulatory affairs and compliance, with experience working with global...
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Regulatory Affairs Specialist Lead
2 days ago
San Diego, California, United States Philips Full timeAbout the RoleWe are seeking a Senior Regulatory Affair Specialist to play a critical role in ensuring Philips Image-Guided Therapy Devices (IGTD) Coronary Vascular (CV) products are safe, effective, and compliant with global regulatory rules and standards.This position reports to the Head of Regulatory Affairs for IGTD-CV and is responsible for advising...
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Regulatory Affairs Director
2 weeks ago
San Diego, California, United States Jobleads-US Full timeThe Senior Director, Global Labeling Regulatory Affairs will lead the development of global labeling for clinical and commercial labeling materials across the product portfolio for Travere products.About the RoleThis role requires a solid understanding of global labeling requirements, labeling platforms, label tracking, change control, and print production...