Regulatory Affairs Specialist
4 days ago
As a key member of our team, you will provide guidance on regulatory requirements and assist in regulatory-related projects and tasks to ensure compliance with FDA regulations, ISO standards, and other regulatory agencies.
Key Responsibilities:
- Develop and implement regulatory strategic plans to ensure compliance with regulatory requirements.
- Represent regulatory affairs on product development and commercialization teams.
- Ensure compliance with standards and execution of corrective actions.
- Prepare and oversee documentation packages for submission to global regulatory agencies.
- Assist with customer complaints and CAPA system.
- Develop risk assessment review process for all marketed devices.
- Monitor proposed and current US and EU regulations and guidance.
- Review documents for regulatory claims and promotional material.
Requirements:
- Strong working knowledge of US and EU regulations that affect Class III medical devices.
- Experience working on cross-functional projects.
- Fluent English with strong written and verbal communication skills.
- Excellent analytical thinking and problem-solving skills.
What We Offer:
- Competitive salaries and performance-based incentives.
- Employer-paid benefits programs.
-
Irvine, California, United States Regulatory Affairs Professionals Society Full timeJoin Our Team:At Regulatory Affairs Professionals Society, we are dedicated to advancing the field of regulatory affairs, particularly within the Critical Care sector. Our mission is to ensure that every patient receives the highest standard of care through innovative medical technologies.Your Role:As a Senior Regulatory Affairs Specialist, you will play a...
-
Irvine, California, United States Regulatory Affairs Professionals Society Full timeJoin Our Team as a Senior Regulatory Affairs Specialist in Critical CareFor over five decades, the Critical Care division at Regulatory Affairs Professionals Society has been at the forefront of pioneering medical advancements and enhancing patient care. Our mission is clear: we strive to ensure that every patient requiring monitoring has access to...
-
Irvine, California, United States Orange County Regulatory Affairs Discussion Group (OCRA) Full timeRegulatory Affairs Senior Consultant, Critical CareCompany: Orange County Regulatory Affairs Discussion Group (OCRA)Position: Senior Regulatory Affairs SpecialistLocation: Remote/HybridOverview: Join a team dedicated to enhancing patient outcomes through innovative regulatory strategies. As a Senior Consultant in Regulatory Affairs, you will play a pivotal...
-
Regulatory Affairs Specialist
1 week ago
Irvine, California, United States Brett Fisher Group Full timeJob DescriptionAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Brett Fisher Group. As a key member of our organization, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key ResponsibilitiesDevelop and implement regulatory strategies to support the...
-
Regulatory Affairs Specialist
5 days ago
Irvine, California, United States Tucker Parker Smith Group (TPS Group) Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tucker Parker Smith Group (TPS Group). As a key member of our team, you will play a critical role in supporting the EU's In Vitro Diagnostic Regulation (IVDR) transition activities for our medical device client.Key ResponsibilitiesTechnical File Revisions: Revising...
-
Regulatory Affairs Specialist
5 days ago
Irvine, California, United States Tucker Parker Smith Group (TPS Group) Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to support our client's transition to the EU's In Vitro Diagnostic Regulation (IVDR). The successful candidate will play a key role in revising technical files, attending project meetings, and ensuring compliance with regulatory requirements.Key ResponsibilitiesTechnical File Revisions:...
-
Regulatory Affairs Consultant
3 weeks ago
Irvine, California, United States Jobot Full timeJoin a reputable medical device organization as a Regulatory Affairs SpecialistThis opportunity is hosted by Jobot.Compensation: $80,000 - $95,000 annuallyAbout Us:We are a leading manufacturer in the medical device sector, seeking a Regulatory Affairs Specialist to enhance our team. Candidates with experience in Class II/III medical devices are encouraged...
-
Regulatory Affairs Specialist
3 days ago
Irvine, California, United States Gable Search Group Full timeJob Title: Regulatory Compliance SpecialistAt Gable Search Group, we are seeking a highly skilled Regulatory Compliance Specialist to join our team.Job Summary:The Regulatory Compliance Specialist will be responsible for ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies. This role will involve providing guidance on...
-
Regulatory Affairs Consultant
3 weeks ago
Irvine, California, United States Inari Medical Full timeThe Regulatory Affairs Specialist operates with a degree of autonomy, providing support to interdisciplinary teams in the formulation and implementation of regulatory strategies for innovative devices and modifications.Key Responsibilities Act as the regulatory liaison for cross-functional project teams.Develop and implement regulatory strategies for new...
-
Lead Regulatory Affairs Consultant
3 weeks ago
Irvine, California, United States myTOD, LLC Full timeSenior Compliance Specialist in Regulatory AffairsAbout myTOD, LLC:myTOD, LLC is at the forefront of Smart Technology, committed to revolutionizing the medical device sector with pioneering solutions that improve patient outcomes. Our advanced products are crafted to adhere to the highest standards of quality and regulatory adherence. As an expanding...
-
Regulatory Affairs Specialist
16 hours ago
Irvine, California, United States University Of California Irvine Full timeAbout the RoleThe University of California, Irvine is seeking a highly skilled Regulatory Affairs Coordinator to join our team at the Center for Clinical Research. As a key member of our team, you will play a critical role in ensuring the successful management of the regulatory aspects of each study conducted through our center.Key ResponsibilitiesManage...
-
Regulatory Affairs Specialist
2 days ago
Irvine, California, United States University Of California Irvine Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team at the University of California, Irvine. The successful candidate will be responsible for ensuring the successful management of the regulatory aspects of each study conducted through our Center for Clinical Research.Key ResponsibilitiesManage regulatory documents,...
-
Compliance and Regulatory Affairs Expert
3 weeks ago
Irvine, California, United States Brett Fisher Group Full timeRegulatory Affairs SpecialistWhy Consider This Opportunity?Brett Fisher Group is a leading entity in the manufacturing and distribution of medical devices, with a strong focus on anesthesia and respiratory solutions. The company has a global presence, operating in numerous countries and maintaining several manufacturing facilities worldwide.The Regulatory...
-
Lead Regulatory Affairs Expert
3 weeks ago
Irvine, California, United States NeuroVasc Technologies, Inc. Full timeCompany Overview:NeuroVasc Technologies, Inc. is committed to delivering excellence through innovation and integrity.Position Summary:The Senior Regulatory Affairs Specialist will report directly to the CEO and will be tasked with planning, directing, and coordinating global product registrations. This role will also lead the planning and execution of...
-
Lead Regulatory Affairs Consultant
3 weeks ago
Irvine, California, United States NeuroVasc Technologies, Inc. Full timeCompany Overview:NeuroVasc Technologies, Inc. is committed to delivering excellence through innovation and integrity in the medical device sector.Position Summary:The Senior Regulatory Affairs Specialist will report directly to the CEO and will be tasked with orchestrating global product registrations and spearheading regulatory submission strategies. This...
-
Regulatory Affairs Specialist
1 day ago
Irvine, California, United States University Of California Irvine Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team at the University of California, Irvine. The successful candidate will be responsible for ensuring the successful management of the regulatory aspects of each study conducted through our Center for Clinical Research.Key ResponsibilitiesManage regulatory documents,...
-
Regulatory Affairs Specialist
2 days ago
Irvine, California, United States University Of California Irvine Full timeAbout the RoleThe University of California, Irvine is seeking a highly skilled Regulatory Affairs Coordinator to join our team at the Center for Clinical Research. As a key member of our team, you will play a critical role in ensuring the successful management of the regulatory aspects of each study conducted through our center.Key ResponsibilitiesManage...
-
Regulatory Affairs Project Manager
2 weeks ago
Irvine, California, United States Elevate Search Full timeJob Summary: Elevate Search is partnering with a leading medical device company to find a highly skilled Regulatory Affairs Project Manager. This individual will play a critical role in the FDA approval process of a groundbreaking implantable device.About the Company: Our partner company is a renowned developer of innovative medical devices, committed to...
-
Irvine, California, United States Skills Alliance Full timeJob Title: Director of Regulatory Affairs and ComplianceJob Type: PermanentLocation: HybridAbout the Role:Skill Alliance is seeking a seasoned Director of Regulatory Affairs and Compliance to lead our regulatory strategy and ensure compliance with global regulations. As a key member of our senior leadership team, you will be responsible for developing and...
-
Regulatory Compliance Specialist
3 weeks ago
Irvine, California, United States Jobot Full timeJoin a Leading Medical Device Company as a Regulatory Affairs SpecialistAbout the Role:We are seeking a talented and experienced Regulatory Affairs Specialist to become a vital part of our team within the medical device sector. This role is essential in maintaining our compliance with various domestic and international regulations, guidelines, and...