Specialist, Regulatory Affairs Jobs

Completes and maintains regulatory approvals and clearances of assigned products.
Key Responsibilities:

• Participate in representing the OUS 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.
• Participate in providing guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals.
• 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, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada]).
• Other incidental duties assigned by Leadership.
• Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content? and guidance on process improvement projects, based on prior experience and responses from affiliates.

Education and Experience:
Bachelor's Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry), 3 years years experience related experience Required or
Master's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry), 1 year years experience Required
3 years years experience preparing domestic and international product submissions Preferred
Additional Skills:

• Solid knowledge and understanding of global regulatory requirements for new products or product changes.
• Ability to interact professionally with all organizational levels
• Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Coursework, seminars, and/or other formal government and/or trade association training required
• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
• Ability to manage competing priorities in a fast paced environment
• Strict attention to detail
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
• Good problem-solving, organizational, analytical and critical thinking skills
• Ability to build productive internal/external working relationships
• Solid knowledge of new product development systems
• Good written and verbal communication skills and interpersonal relationship skills

About Edwards Lifesciences
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 18,500 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.
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.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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