Specialist, Regulatory Affairs

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex 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.

How you’ll make an impact:

• Ensure devices are compliant with national regulations and fully registered as appropriate; align regulatory activities with operating plans as well as ensuring alignment in assigned countries.
• Participate in providing guidance and feedback to local stakeholders on regulatory activities (e.g., strategies, contingency plans, registration requirements) including assessing impact to appropriate regulations.
• Support local commercial and clinical teams with regulatory input and guidance.
• Identify and develop moderately complex Regulatory Affairs process improvement initiatives including system enhancements, training, reports and/or dashboards including executing all RA activities in Edwards systems to ensure compliant product distribution.
• Identify trends, assess impact, analyze alternatives and recommend action plans
• Participate in representing the regulatory function in internal and external meetings
• Incidental: Other duties as assigned by Management

What you'll need:

• Bachelor's Degree in scientific discipline (e.g. Engineering, Biology, Physics, Chemistry etc.) & 2+ years of experience in Regulatory Affairs is a must
• Proficiency in English & Dutch required , French is a plus
• Solid knowledge and understanding of EU regulations relevant to medical devices for new products or product changes & experience in preparing domestic/international product submissions.
• Strong written and verbal communication skills and interpersonal relationship skills
• Good problem-solving, decision-making, organizational skills and strong attention to detail

What is it like to work at Edwards Lifesciences in Belgium?

As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.

We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).

Edwards Lifesciences in Belgium also offers the following benefits:

• Competitive Compensation and Benefits package
• Flexible working hours, home office possibility
• Pension plan
• Death and Disability Insurance
• Health Insurance
• Transportation Programs
• Service Awards
• Enhanced Annual Leave
• Employee Stock Purchase Program
• Employee Assistance Program
• Comprehensive Well-being Program including onsite fitness room, fresh fruit in the office, access to Headspace membership, educational events, charity activities and much more.

Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefits policy and components may vary by location.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease and critical care monitoring

What we offer

Diversity, inclusion & belonging

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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.