Job Description

Key Responsibilities:

• Perform regulatory submission tasks independently mandated by existing local healthcare regulations and internal procedures, including on-time renewal submission, new product registration, product change submissions, recall notifications etc.
• Perform the regulatory operational tasks independently in internal systems (ePAC, Ignite, iRAMS etc.) and maintain the proper regulatory dossier trackers and records in the relevant systems.
• Contribute in developing the regulatory strategy, prioritize submissions/tasks as well as contribute to achieve the country KODs as per defined internal operating plans.
• Contribute in the follow-up meetings and conferences with regulatory authorities to remain up to date with regulation changes and industry trends.
• Implement other internal regulatory compliance processes and contribute to the process improvement.
• Other incidental duties: provide regulatory support to other relevant local or global cross-functional projects.

Education and Experience:

• Master's Degree or equivalent in at least in related field.
• 3 years years experience of previous medical device regulatory and/or clinical experience Required.
• Other: in scientific discipline (e.g., Pharma, Biology, Microbiology, Chemistry) Preferred.

Additional Skills:

• Excellent written and verbal communication skills including negotiating and relationship management skills.
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices.
• Full knowledge and understanding of global regulatory requirements for new products or product changes..
• Full knowledge of new product development systems.
• Good foundation in the regulatory profession, including regulatory process management and related complex problems.
• Capability to work independently at regulatory submissions and operational tasks.
• Integrate and demonstrate core values, integrity and accountability throughout the organization and externally.
• Ability to interact professionally with internal cross-functional team members and regulatory authorities.
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel.
• Strict attention to detail.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast paced environment.
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
• 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.

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 13,000 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.
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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