We have other current jobs related to this field that you can find below
-
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 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 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...
-
Senior Specialist, Regulatory Affairs, Critical Care
2 months ago
Irvine, United States Orange County Regulatory Affairs Discussion Group (OCRA) Full timeSenior Specialist, Regulatory Affairs, Critical Care Company: Edwards Lifesciences LLC Position: Req-33420 Location: Irvine, CA Posted: May 13, 2024 Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Irvine, United States myTOD, LLC Full timeSenior Regulatory Affairs Specialist Location: Irvine About OrthAlign, Inc.: OrthAlign, Inc. is a leader in Smart Technology, dedicated to transforming the medical device industry with innovative solutions that enhance patient outcomes. Our cutting-edge products are designed to meet the highest standards of quality and regulatory compliance. As a growing...
-
Senior Regulatory Affairs Specialist
3 weeks ago
Irvine, United States myTOD, LLC Full timeSenior Regulatory Affairs SpecialistLocation: IrvineAbout OrthAlign, Inc.:OrthAlign, Inc. is a leader in Smart Technology, dedicated to transforming the medical device industry with innovative solutions that enhance patient outcomes. Our cutting-edge products are designed to meet the highest standards of quality and regulatory compliance. As a growing...
-
Senior Regulatory Affairs Specialist
3 weeks ago
Irvine, United States myTOD, LLC Full timeSenior Regulatory Affairs SpecialistLocation: IrvineAbout OrthAlign, Inc.:OrthAlign, Inc. is a leader in Smart Technology, dedicated to transforming the medical device industry with innovative solutions that enhance patient outcomes. Our cutting-edge products are designed to meet the highest standards of quality and regulatory compliance. As a growing...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Irvine, United States NeuroVasc Technologies, Inc. Full timeWe are NeuroVasc Technologies! We deliver excellence through innovation with integrity.This role is on-site. Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Irvine, United States NeuroVasc Technologies, Inc. Full timeWe are NeuroVasc Technologies! We deliver excellence through innovation with integrity.This role is on-site. Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional...
-
Senior Regulatory Affairs Specialist
3 months ago
Irvine, United States NeuroVasc Technologies, Inc. Full timeWe are NeuroVasc Technologies! We deliver excellence through innovation with integrity.Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory Affairs colleagues...
-
Senior Regulatory Affairs Specialist
3 months ago
Irvine, United States NeuroVasc Technologies, Inc. Full timeWe are NeuroVasc Technologies! We deliver excellence through innovation with integrity.Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory Affairs colleagues...
-
Irvine, United States Regulatory Affairs Professionals Society Full timeFor over 50 years, the Critical Care product group within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology. If you're a dynamic...
-
Lead Regulatory Affairs Consultant
7 days 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 Consultant
7 days 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...
-
Lead Regulatory Affairs Expert
7 days 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
7 days 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
3 days ago
Irvine, United States Elevate Search Full timeElevate Search is partnering with an Irvine-based medical device company developing an implantable breakthrough device for the US population to find a Regulatory Affairs Project Manager. This person will report to the Director of Regulatory Affairs.This is an extremely exciting opportunity to assist with the FDA approval of a groundbreaking device (patients...
-
Regulatory Affairs Specialist
4 days ago
Irvine, United States Elevate Search Full timeElevate Search is partnering with an Irvine-based medical device company developing an implantable breakthrough device for the US population to find a Regulatory Affairs Project Manager. This person will report to the Director of Regulatory Affairs.This is an extremely exciting opportunity to assist with the FDA approval of a groundbreaking device (patients...
-
Regulatory Affairs Consultant
7 days 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...
-
Regulatory Affairs Specialist
2 months ago
Irvine, United States Motion Recruitment Full timeJob Title: Regulatory Affairs Specialist📍 Location: Irvine CA, Onsite📆 Duration: 6+/12+ MonthsAbout the Client:Join a global leader in the Medical Devices Industry, specializing in artificial heart valves and hemodynamic monitoring.Typical Task Breakdown:• Create regulatory submissions (exercising judgment to protect proprietary information) for...
![NeuroVasc Technologies, Inc.](https://media.trabajo.org/img/noimg.jpg)
Senior Regulatory Affairs Specialist
1 month ago
We are NeuroVasc Technologies We deliver excellence through innovation with integrity.
Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory Affairs colleagues to drive timely and accurate submission development and applications.
Duties and Responsibilities include... • Manages and coordinates international product registration submissions, oversees status of internal regional regulatory activities; ensures compliance with relevant regulations and standards.* • Leads Regulatory on Global product registrations in a timely manner to meet the needs of the business for product growth and geographical expansion.* • Actively engages with cross-functional teams (as required) to plan for and provide regulatory guidance, services, and capabilities to support planned product launch and market expansion.* • Coordinates (pre) submissions and approval of all applications, ensuring they are accurate and appropriate to the requirements of the regions.* • Plans and tracks specified product registration and renewal activity, ensuring alignment with portfolio priorities throughout the registration and renewal processes; manages expirations / renewals and planning for new applications.* • Manages and oversees relationships and interactions with Health Authorities (HAs) to ensure the company’s knowledge of requirements and expectations is current and robust; shares this regulatory intelligence with colleagues to ensure the company is informed of opportunities and risks.* • Participates in any relevant regulatory improvement projects.
Education and Experience: • Bachelor’s degree or higher in Life Sciences, Engineering, or related disciplines. • Minimum of 5 years’ plus experience in Regulatory Affairs. • Experience working with Class I, II and III medical devices. • Deep understanding of relevant laws, regulations, and guidelines governing the development, approval, and marketing of medical devices. • Proven knowledge of regulatory requirements and experience preparing international documents, such as STEDs, Design Dossier, and Technical Files and new products registration for Non-EU, Canada, LATAM, APAC (Australia, New Zealand, Korea, Taiwan, and Singapore), and EMEA. • Strong working knowledge of EU (MDD / MDR) medical device regulations and submissions. • Experience and proven ability in preparing US regulatory submissions e.g., IDE, 510(k), PMA, and technical documentation. • Knowledge of Quality Systems requirements such as QSR, ISO 13485, GxP. • Strong leadership and project management skills and ability to manage complex projects and timelines within a team environment. • Ability to identify compliance risks and escalate when necessary. • Demonstrated ability to stay abreast of changing regulations and standards. • Excellent computer aptitude and document formatting and publishing skills. • Strong problem-solving skills and ability to deal with changing priorities.
NeuroVasc is an equal opportunity employer.
Salary range is $100-$150K