Senior Regulatory Specialist

2 months ago

California, United States Edwards Lifesciences Full time
About Edwards Lifesciences

Edwards Lifesciences is a leading global medical technology company that specializes in the development, manufacturing, and marketing of innovative medical devices. Our mission is to improve the quality of life for patients around the world by providing cutting-edge medical solutions.

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices. This is a critical role that requires strong analytical and problem-solving skills, as well as excellent communication and collaboration skills.

Key Responsibilities
  • 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.
  • 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.
  • 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.
Requirements
  • Bachelor's Degree in a related field and 5 years of previous related experience
  • OR Master's Degree in a related field and 3 years of previous related experience
  • Coursework, seminar, and/or other formal government and/or trade association training
Preferred Qualifications
  • Bachelor's or Master's degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry)
  • Experience in preparing EU design dossiers or technical files and US 510(k)s
  • Full knowledge and understanding of EU and US regulations relevant to medical devices, Class II and/or Class III devices
  • Full knowledge and understanding of EU and US requirements for product changes for disposable marketed products (catheters, minimally invasive sensors, pressure monitoring devices, blood management devices)
  • Full knowledge of change management systems
  • Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
  • Excellent written and verbal communication skills including negotiating and relationship management skills
  • Excellent problem-solving, organizational, analytical and critical thinking skills
  • Strict attention to detail
What We Offer

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 Career website.

Equal Opportunity Employer

Edwards Lifesciences is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards Lifesciences 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.

  • Senior Specialist, Regulatory Affairs, Critical Care

    2 weeks ago

    California, United States Edwards Lifesciences Full time

    Make a Meaningful Difference in Regulatory AffairsAt Edwards Lifesciences, we're committed to creating a world where every patient who should be monitored will be monitored with smart technology. As a Senior Specialist, Regulatory Affairs, Critical Care, you'll play a critical role in helping us achieve this vision.Key Responsibilities:Represent the...

  • Senior Regulatory Affairs Director

    2 months ago

    California, United States The Mullings Group Full time

    Job Title: Senior Regulatory Affairs LeaderAbout The Mullings Group: A leading consulting firm specializing in medical device regulatory affairs and strategic business development.Job Summary: We are seeking a highly experienced Senior Regulatory Affairs Leader to spearhead all FDA Pre-Market Approval submission activities as well as post-market supplements...

  • Regulatory Compliance Specialist

    4 weeks ago

    California, United States Rare Beauty Full time

    Regulatory Specialist - R&DRare Beauty is a pioneering company that challenges beauty norms by promoting self-acceptance and mental health. We're seeking a highly skilled Regulatory Specialist - R&D to join our growing team.Key Responsibilities:Oversee daily regulatory operations, ensuring compliance with international cosmetic regulations.Develop and...

  • Regulatory Affairs Specialist

    1 month ago

    California, United States Edwards Lifesciences Full time

    Make a Meaningful Difference in Critical CareAt Edwards Lifesciences, we're committed to creating a world where every patient who should be monitored will be monitored with smart technology. As a Regulatory Affairs Specialist, you'll play a critical role in helping us achieve this vision.Your ImpactRepresent the regulatory function on manufacturing and...

  • Regulatory Affairs Specialist

    2 weeks ago

    California, United States Edwards Lifesciences Full time

    Make a Meaningful Difference in Regulatory AffairsAt Edwards Lifesciences, we're committed to creating a world where every patient who should be monitored will be monitored with smart technology. As a Regulatory Affairs Specialist, you'll play a critical role in helping us achieve this vision by ensuring our innovative technologies meet complex domestic and...

  • Senior Regulatory Affairs Director

    2 months ago

    California, United States The Mullings Group Full time

    Job SummaryThe Mullings Group is seeking a highly skilled Senior Regulatory Affairs Leader to spearhead all FDA Pre-Market Approval submission activities as well as post-market supplements and international product registrations for our client, a transformational new medtech start-up utilizing advanced robotics to combat structural heart disease.About the...

  • Regulatory Affairs Specialist

    3 weeks ago

    California, United States Edwards Lifesciences Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Edwards Lifesciences. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key ResponsibilitiesRepresent the regulatory function on manufacturing and...

  • Senior Regulatory Counsel

    2 weeks ago

    California, Missouri, United States Counsel Treuhand GmbH Full time

    About the TeamOur Legal team plays a vital role in advancing OpenAI's mission by tackling innovative and complex legal issues in AI. If you're passionate about doing significant and unique work as a technology lawyer, this team is for you. The team comprises professionals from diverse fields, including technology, AI, privacy, IP, corporate, employment, tax...

  • Regulatory Affairs Expert

    1 month ago

    California, United States BioTalent Full time

    BioTalent is seeking a seasoned Regulatory Affairs Specialist to drive regulatory strategies and submissions for medical devices. As a key member of our team, you will develop and implement global regulatory strategies for clinical applications in various markets. Your expertise will be crucial in managing regulatory submissions, collaborating with clinical...

  • Regulatory Affairs Director

    4 weeks ago

    California, United States Meet Full time

    Regulatory Affairs and Quality Assurance LeaderWe are seeking a seasoned Regulatory Affairs and Quality Assurance professional to join our client's team as a Vice President/Senior Vice President. This hybrid role will be based in the San Francisco Bay Area and will report directly to the C-Suite.Key Responsibilities:Lead the Regulatory Affairs and Quality...

  • Director of Regulatory Affairs

    4 weeks ago

    California, United States Bow and Arrow Holdings, LLC Full time

    Job Title: Director of RegulatoryCompany OverviewBow and Arrow Holdings, LLC is a leading provider of flexible infrastructure solutions. Our mission is to generate life-long current yield for our partners and shareholders by delivering resilience and independence to our customers.Job SummaryWe are seeking an experienced Director of Regulatory to join our...

  • Senior Blockchain Security Specialist

    2 weeks ago

    California, United States Understanding Recruitment Full time

    Senior Blockchain Security SpecialistWe are seeking a Senior Blockchain Security Specialist to join our open-source blockchain team creating a high-performance network that focuses on real-world applications such as enabling payments and providing aid while supporting 8 million users.This company interacts with some of the largest and most respected...

  • Senior Drafting Specialist

    1 month ago

    California, United States Morgner Construction Management Corp. Full time

    Senior Drafting SpecialistMorgner Construction Management Corp. is seeking a highly skilled Senior Drafting Specialist to join our team in the Building Engineering Unit (BEU) at LAWA. The selected candidate will work alongside a multi-disciplined team of planners, architects, engineers, construction managers, and other professionals in a collaborative...

  • Director of Regulatory Affairs

    4 weeks ago

    California, USA, United States Bow and Arrow Holdings, LLC Full time

    Job Title: Director of Regulatory AffairsWe are seeking an experienced Director of Regulatory Affairs to join our team at Bow and Arrow Holdings, LLC. As a key member of our organization, you will be responsible for developing and executing advocacy strategies that support distributed generation development on residential real estate in our target...

  • Senior Financial Reporting Specialist

    1 month ago

    California, United States Hamlyn Williams Full time

    Senior Financial Reporting AnalystWe are partnering with a highly reputable company in Downtown LA to find a Senior Financial Reporting Analyst to join their team. This role will play a key part in shaping both internal and external financial reports, including SEC filings and regulatory reports.Key Responsibilities:Manage key regulatory reports, such as...

  • Regulatory Lawyer, AI Research and Development

    6 days ago

    California, Missouri, United States Counsel Treuhand GmbH Full time

    About the TeamAt Counsel Treuhand GmbH, our Legal team plays a pivotal role in advancing our mission by tackling innovative, fundamental legal issues in AI. If you're passionate about doing significant and unique work as a technology lawyer, this team is for you. The team comprises professionals from diverse fields, including technology, AI, privacy, IP,...

  • Senior Paid Search Specialist

    4 weeks ago

    California, Missouri, United States CoStar Group Full time

    Senior Paid Search SpecialistCoStar Group is seeking an experienced Senior Paid Search Specialist to join our team. As a key member of our digital marketing team, you will be responsible for managing our multi-million dollar paid search budget and driving business growth through data-driven decision making.Responsibilities:Manage in-house Google and Bing...

  • LPN - Nursing Care Specialist

    2 weeks ago

    California, United States Discovery Senior Living Full time

    About the RoleAt Discovery Senior Living, we are seeking a skilled Licensed Practical Nurse (LPN) to join our team. As an LPN, you will play a vital role in providing high-quality nursing care to our residents, ensuring their physical and emotional well-being.Key ResponsibilitiesProvide comprehensive nursing care to residents, including health evaluations,...

  • Senior Validation Specialist

    1 month ago

    California, United States BioPhase Full time

    Job Title: Senior Validation EngineerAt BioPhase, we are seeking a highly skilled Senior Validation Engineer to join our Quality Engineering team. As a key member of our team, you will be responsible for ensuring the quality and integrity of our products and processes.Key Responsibilities:Support the Quality Engineering group with documentation and...

  • Senior Manager of Statistical Programming

    1 month ago

    California, United States Meet Full time

    Senior Manager, Statistical ProgrammingWe are seeking an experienced SAS programmer to fill a Senior Manager of Statistical Programming opening. This role will involve hands-on programming for clinical studies, including exploratory analyses, regulatory responses, and defense activities.Key Responsibilities:Conduct programming for individual and pooled...