Team Lead RA – Complaint Handling (32 - 40hrs per week)

Overview:

Job Description:

Are you a natural born leader who loves to create a climate that empowers team members to achieve their goals?

Does working in the Head Office of one of the most progressive Medical Device Manufacturers sound exciting?

Applied Medical gives you the opportunity to contribute to our global mission of high standards of integrity and social responsibility. As our Regulatory Affairs Team Leader you will be responsible for leading and overseeing European post market regulatory activities. You will be leading a team of Post Market Regulatory Affairs specialists (junior and senior) and will be responsible for complaint handling, vigilance reporting, communication with competent authorities, field action evaluation and coordination, etc. You and your team will also be responsible for training other teams and departments on post market related topics and contribute to related projects and activities, while supporting compliance with applicable regulations.

To realize this, you will work closely together with multiple teams and functions throughout the organization such as Customer Service, Quality, Sales, Product Management, the Post Market Regulatory Affairs team in the US, etc.. You will act as our subject matter expert, and you can be contacted by anyone in the organization for post market regulatory related topics.

You will report to the Manager Regulatory Affairs.

Key Responsibilities* Be responsible for Post Market regulatory compliance in Europe

• Drive process improvements within the team, the department and the organization
• Define team goals in line with Applied Medical’s vision and plan
• Guide and lead the team members in implementing set goals by creating an empowering and safe environment for them
• Act as subject matter expert in Post Market Regulatory related processes
• Ensure continuous compliance with all applicable laws and regulations
• Monitor and Analyze Post Market data
• Create a team member related planning such as onboarding and succession planning, development planning, etc.

Requirements:

• Bachelor’s degree (HBO) in engineering, life sciences related studies, or similar
• At least 3 years’ experience working within a regulatory affairs related discipline
• 1 to 2 years' experience in a supervisory role
• Excellent knowledge of major medical device standards and regulations
• Excellent oral and written communication skills in English

We Offer:

• An international working environment, fueled by respect and a healthy work-life balance tailored to the business and team member’s needs
• 27 paid vacation days (based on fulltime contract) with option to purchase five additional days
• This is mainly an on-site role
• Commuting allowance of €0,23/km or full coverage of public transportation costs
• A wide variety of internal trainings and development possibilities and a tuition program for external trainings
• The opportunity to pro-actively work on your vitality and fitness
• State-of-the-art facilities, including green areas, in-house restaurant and gym
• Additional benefits, such as:
  • Attractive pension scheme (your contribution at 4%, ours at 12%)
  • €50 net monthly health insurance contribution
  • Two (paid) days per year dedicated to volunteering activities
  • Several fun company events and meaningful initiatives organized throughout the year

At Applied Medical, we are committed to make a meaningful, positive difference, each and every day. Within our European headquarters in Amersfoort (NL), we develop, manufacture and support the implementation of our advanced medical devices across Europe and the MENA region. Applied’s team members enjoy working in an environmentally friendly and international environment, in which people of diverse backgrounds are valued, challenged, and acknowledged. We support our team members by giving them opportunities of ongoing learning and education, possibilities to take part in community voluntee