Senior Specialist, Regulatory Affairs

3 weeks ago

Irvine, United States CareerBuilder Full time

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience.

Senior Specialist, Regulatory Affairs page is loaded

Senior Specialist, Regulatory Affairs

Apply

locations

USA - California Irvine

time type

Full time

posted on

Posted 2 Days Ago

job requisition id

Req-31674

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients lives.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patients unmet clinical needs. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How you will make an impact:
As a Senior Specialist, Regulatory Affairs for TMTT, you will complete and maintain clinical and commercial regulatory approvals of Class III implantable products in the US and EU, focusing on the paradigm shifting transcatheter tricuspid valve replacement therapy.
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps management apprised of alternative actions.

Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.

Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans

Prepare and oversee documentation packages for submission to global regulatory agencies.

Assist with GUDID submissions.

Track timelines and documents milestone achievements for inclusion in regulatory submissions.

May interact with regulatory agencies as part of submission review and on-site audit support. (e.g., IDEs, PMAs, annual reports, 510(k)s, STEDs and CE marking design dossiers and technical files)

Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process

Review labeling content product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy

What youll need (Required):
Masters degree and 6 years of previous related experience

OR

Bachelors degree and 8 years of previous related experience

Coursework, seminars and/or other formal government and/or trade association training

What else we look for (Preferred):
Experience in preparing domestic and international product submissions

Extensive knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices

Extensive knowledge and understanding of global regulatory requirements for new products or product changes

Extensive knowledge of new product development systems

Ability to interact with regulatory agencies and international regulatory partners

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $88,000 to $124,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Applications will be accepted while this position is posted on our Careers website.
E dwards is an Equal

Opportunity/Affirmative

Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

About Us

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

#J-18808-Ljbffr

  • Senior Specialist, Regulatory Affairs

    2 weeks ago

    Irvine, United States Orange County Regulatory Affairs Discussion Group (OCRA) Full time

    Senior Specialist, Regulatory Affairs, Sustaining Products, THV The Regulatory Affairs Senior Specialist role is an outstanding opportunity to be a part of the Edwards Lifesciences Transcatheter Heart Valve (THV) program, one of the medical device industry’s most groundbreaking technological innovations. Edwards has a strong pipeline in this space and the...

  • Senior Specialist, Regulatory Affairs, Critical Care

    18 hours ago

    Irvine, United States Orange County Regulatory Affairs Discussion Group (OCRA) Full time

    Senior 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 Infosoft, Inc. Full time

    Job Title: Senior Regulatory Affairs SpecialistDuration: 9 monthsLocation: Irvine, CA (Onsite)Shift: 8 am to 5 pm.Our Client is a Global medical device Manufacturer.We are looking for a Senior Regulatory Affairs Specialist to complete and maintain regulatory approvals and clearances of assigned products.Create regulatory submissions (exercising judgment to...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Irvine, United States Infosoft, Inc. Full time

    Job Title: Senior Regulatory Affairs SpecialistDuration: 9 monthsLocation: Irvine, CA (Onsite)Shift: 8 am to 5 pm.Our Client is a Global medical device Manufacturer.We are looking for a Senior Regulatory Affairs Specialist to complete and maintain regulatory approvals and clearances of assigned products.Create regulatory submissions (exercising judgment to...

  • Senior Regulatory Affairs Specialist

    7 days ago

    Irvine, United States NeuroVasc Technologies, Inc. Full time

    We are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world. 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...

  • Senior Regulatory Affairs Specialist

    4 weeks ago

    Irvine, United States NeuroVasc Technologies, Inc. Full time

    We are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world. 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...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Irvine, United States NeuroVasc Technologies, Inc. Full time

    We are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world. 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...

  • Senior Regulatory Affairs Specialist

    4 weeks ago

    Irvine, United States NeuroVasc Technologies, Inc. Full time

    We are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world. 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...

  • Regulatory Affairs Consultant

    6 days ago

    Irvine, United States Redbock - an NES Fircroft company Full time

    Regulatory Affairs Consultant Irvine, CA A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a Regulatory Affairs Consultant to support them for approximately 3 months . The consultant will need to work onsite at least 3 days/week . The Regulatory Affairs Consultant will be focused on the hands-on development of a Special...

  • Regulatory Affairs Consultant

    1 week ago

    Irvine, United States Redbock - an NES Fircroft company Full time

    Regulatory Affairs Consultant Irvine, CA A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a Regulatory Affairs Consultant to support them for approximately 3 months. The consultant will need to work onsite at least 3 days/week. The Regulatory Affairs Consultant will be focused on the hands-on development of a Special...

  • Regulatory Affairs Consultant

    2 weeks ago

    Irvine, United States Redbock - an NES Fircroft company Full time

    Regulatory Affairs ConsultantIrvine, CAA fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a Regulatory Affairs Consultant to support them for approximately 3 months. The consultant will need to work onsite at least 3 days/week. The Regulatory Affairs Consultant will be focused on the hands-on development of a Special 510k...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, United States Cypress HCM Full time

    · 0-2 years of experience in regulatory affairs, and/or experience in QA, R&D, Manufacturing or Project Management within the IVD industry· Working knowledge of FDA, and CE marking requirements for IVD products is a plus· Able to work independently and with others· Able to work with minimal supervision· Excellent computer applications skills· Strong...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, United States Cypress HCM Full time

    · 0-2 years of experience in regulatory affairs, and/or experience in QA, R&D, Manufacturing or Project Management within the IVD industry· Working knowledge of FDA, and CE marking requirements for IVD products is a plus· Able to work independently and with others· Able to work with minimal supervision· Excellent computer applications skills· Strong...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, United States Cypress HCM Full time

    · 0-2 years of experience in regulatory affairs, and/or experience in QA, R&D, Manufacturing or Project Management within the IVD industry· Working knowledge of FDA, and CE marking requirements for IVD products is a plus· Able to work independently and with others· Able to work with minimal supervision· Excellent computer applications skills· Strong...

  • Regulatory Affairs Specialist- Irvine

    2 weeks ago

    Irvine, United States Hydrogen Group Full time

    Are you passionate about navigating global regulatory landscapes and ensuring the compliance of life-saving medical devices? We're looking for a skilled Regulatory Affairs Specialist to join a vibrant team in Irvine, CA! This medical device company are pioneering innovative medical solutions that enhance patient care worldwide. Their International...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, United States Trinus Full time

    Job DescriptionJob DescriptionSummary: The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products.Key Responsibilities: Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and...

  • Director, Safety. Regulatory Affairs and Medical Affairs Quality Standards

    5 days ago

    Irvine, California, United States AbbVie Full time

    Job Description Purpose: AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research & development, R&D Quality Assurance (RDQA) is committed to driving quality excellence...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Irvine, United States Cynet Systems Full time

    Job Description:Pay Range $44.60hr - $49.60hrResponsibilities:Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy.Participate in providing guidance on strategies and...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Irvine, United States Cynet Systems Full time

    Job Description: Pay Range $44.60hr - $49.60hr Responsibilities: Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy. Participate in providing guidance on strategies and...

  • Senior Regulatory Labeling Specialist

    1 week ago

    Irvine, United States Medtronic, plc Full time

    Help with development of US and International regulatory strategies for product submissions. Assist in keeping company informed of regulatory requirements in the US and International Regions Participate on Product Development teams, providing regulat Regulatory, Neuro, Senior, Specialist, International, Technical, Manufacturing, Technology