Specialist, Regulatory Affairs Surgical

Specialist, Regulatory Affairs Surgical Edwards Lifesciences - 3.9 Irvine, CA Job Details Full-time $74,000 - $104,000 a year 1 hour ago Qualifications Biology FDA submissions Medical law Technical documentation Bioengineering Collaborating with government agencies Mid-level 3 years Microbiology Bachelor's degree in biology Collaboration with product development teams Bachelor's degree Compliance documentation Contingency planning Chemistry Regulatory submission editing and review Biomedical regulatory compliance Communication with regulatory authorities for clinical trials Bachelor's degree in microbiology Content review Bachelor's degree in chemistry Progress tracking (project management tasks) Audit support Full Job Description 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 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. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's 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: 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 conflicts between those requirements and development issues, and/or reporting to management Prepare and oversee documentation packages for submission to global regulatory agencies. 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., IDE's, PMA's, annual reports, 510(k)'s, STED's and CE marking design dossiers and technical files) Provide guidance on regulatory requirements necessary for contingency planning Monitor proposed and current global regulations and guidance; assesses impact of such regulations and guidance on assigned project(s); proposes 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 Prepare documents for submissions, including assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissions What you will need (Required): Bachelor's Degree & a minimum of 3 years related experience or equivalent experience based on Edwards criteria Coursework, seminars, and/or other formal government and/or trade association training What else we look for (Preferred) : Bachelor's Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry, Bioengineering) Experience in preparing domestic and international product submissions Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices Solid knowledge and understanding of global regulatory requirements for new products or product changes 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 $74,000 - $104,000 (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. #LI-Onsite E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require

COVID-19

vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.