Specialist, Regulatory Affairs
Edwards Lifesciences
- Brussel
- Vast
- Voltijds
- 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
- 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
- Competitive Compensation and Benefits package
- Flexible working hours, home office possibility
- Pension plan
- Death and Disability Insurance
- Health Insurance
- Meal Benefits
- 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.