Key Responsibilities:
- Prepare and review product registration tasks covering the new product registration, progress reports, supplements, amendment, periodic reports and the renewal registration.
- Support and coordinate with other functions to fulfill company’s regulatory tasks mandated by other existing local healthcare regulations, such as the completion of the device registration and tracking monthly reports, the device advertising application, the facilitation of device import exemption and other new regulatory requirement projects assigned by the authority bodies.
- Maintain good relationship with government authorities to keep up to date on regulations changes and trends; seek advice on interpretation of government guidelines and regulations to ensure compliance.
- Support and carry out company internal regulatory, quality and compliance processes investigation, recall FDA reporting.
- Track timelines and document milestone achievements, develop regulatory strategy, prioritize strategies/submissions with operating plans as well as ensuring alignment with KOD in country/regions and provide regulatory updates to relevant stakeholders.
- Obtain approvals from Ministry of Health/ Pricing Bureau/ other relevant authorities on the pricing and reimbursement levels.
- Provide guidance and feedback to BUs on registration requirements for new and renewal registrations, product and process changes, and review of labeling content and guidance on process improvement projects.
- Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements.
- Strict attention to detail.
- Bachelor's Degree in related field.
- 5 Years previous experience related in coursework, seminars, and/or other formal government and/or trade association training Required and
- Bachelor's Degree in Scientific discipline (e.g., medical, pharma, Biology, Microbiology, Chemistry)Experience in preparing domestic and international product submissions Preferred.
- 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.
- Full knowledge and understanding of country/regions regulations relevant to medical devices, Class II and/or Class III devices.
- Full knowledge and understanding of country/ regions regulatory requirements for new products or product changes.
- Good leadership skills and ability to influence change.
- Strict attention to detail.
- Ability to interact professionally with all organizational levels.
- Ability to manage competing priorities in a fast paced environment.
- Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness.
- 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
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.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice
