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Job Post Details

Regulatory Affairs Specialist, Post Market (32 - 40hrs per week) - job post

Applied Medical Europe B.V.
3.1 van de 5 sterren
3815 Amersfoort

Locatie

3815 Amersfoort

Volledige vacaturetekst

Overview:
Job Description:
Are you enthusiastic about building your career in regulatory affairs and eager to deepen your expertise in post market product support?
We are looking for a driven Regulatory Affairs Specialist to join our Post Market Regulatory Team at Applied Medical’s European headquarters in Amersfoort (NL).

In this role, you will be a key member of a small and highly collaborative sub team focused on complaint handling and post market regulatory activities.
You will be responsible for coordinating all regulatory efforts related to customer complaints processing, ensuring timely and accurate reporting to European authorities.
The position plays a coordinating role, ensuring smooth collaboration between field teams, internal departments, and external parties.
You will work closely with Customer Service, Quality, Sales, our U.S. Regulatory team, and external customers to ensure complaint data is handled, processed, and communicated with the highest level of quality and accuracy.
The Post Market team consists of seven members, with the immediate sub-team including four specialists.

Key Responsibilities
  • Review and verify complaint data to ensure accurate and complete regulatory reporting
  • Submit mandatory reportable events to European authorities within strict timelines and track all follow up activities
  • Review and prepare final responses and closing reports
  • Ensure compliance with European regulations and internal quality and reporting standards
  • Collaborate closely with QA Engineers responsible for technical complaint investigations
  • Support additional regulatory activities such as recall notifications, and internal/external regulatory requests
Requirements:
  • Bachelor’s degree (HBO) in Engineering, Medical Affairs, Regulatory Affairs or related field
  • 1+ years relevant working experience
  • Excellent oral and written communication skills in English
  • Knowledge of another European language is a plus
  • Experience in Medical Devices, knowledge of Quality Management System, ISO or CE marking is a plus
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 with hybrid options
  • 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 volunteering activities and a variety of onsite exercise classes and health activities.

If you are passionate about working in an organization that allows you to make decisions based upon what is right for the patient, customer, community and environment, Applied Medical is the place for you.

Interested?

Would you like to be part of our expanding team? If the answer is yes, we'd love to get to know you and look forward to hearing from you!
For more information regarding our hiring process, click here. If you have any questions, feel free to contact us via TA-Europe@appliedmedical.com or +31 (0)33 7548713.

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