Regulatory Affairs Associate - Post Market Surveillance
Amersfoort, Utrecht, Netherlands · Hybrid
Entry level
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Team Lead RA – Complaint Handling (32 - 40hrs per week)
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Regulatory Affairs Associate - Post Market Surveillance
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Full-time
bachelor degree
27 Paid vacation days, Option to purchase five additional vacation days, Commuting allowance, Public transportation cost coverage, Internal trainings and development possibilities, Tuition program for external trainings
Posted 42d ago
Apply by Jun 30
~40 hrs/week
Responsibilities
The role involves receiving and processing field complaints to ensure regulatory compliance with regional and international laws. Key tasks include submitting mandatory reportable events to European authorities and collaborating with internal stakeholders for trending and reporting.
Requirements
Candidates need a Bachelor's degree in healthcare or engineering, or equivalent experience in Regulatory Affairs. At least one year of relevant working experience in an international environment and the right to work in the Netherlands are required.
Full job description
Are you organized, adaptable, and energized by working in a fast-paced environment?
Do you pride yourself on communication and collaboration skills, and would you like to join an international and forward-thinking medical devices company?
Applied Medical might be the next step in your career!
Our Regulatory Affairs Post-market team at Applied Medical’s European headquarters in Amersfoort (NL) is looking for a Regulatory Affairs Associate – Post Market Complaint Processing, that keeps their head cool when things get hectic.
In this hands-on role, you will be responsible for supporting various post market activities within the organization to facilitate regulatory compliance with regional and international laws and regulations. This includes receiving and processing complaints from the field, and ensuring that effective reporting, trending, communication, and correct actions are taken.
To succeed and thrive in a structured but dynamic environment, you communicate effectively with different stakeholders and can prioritize pending tasks to meet deadlines.
This position is based in our European Headquarters in Amersfoort and reports to the Team Leader RA Post Market Complaint Processing
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
Collaborate with the other teams to acquire additional information to support the complaint and the decisions made as a result
Interact and communicate with internal and external stakeholders in order comply with due dates and procedures.
Support senior team members in the execution of their tasks
Initiate and support operational projects within the RA department
What you bring
Bachelor’s degree (HBO) in the field of healthcare or engineering, or experience in Regulatory Affairs
At least 1 year relevant working experience
Working experience in an international environment
Excellent oral and written communication skills in English, knowledge of any other European language is a plus
Ability and right to work in the Netherlands
What 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 [email protected].
Not the right job for you? Take a look at our other vacancies and follow us on LinkedIn.
As a new generation medical device company, Applied Medical is focused on meeting three fundamental healthcare needs: enhanced clinical outcomes, cost containment and unrestricted choice. Our vertically integrated programs in design, development, manufacturing, and distribution enable us to consistently meet these objectives. As a vertically integrated company, we manufacture all of our products in-house at our corporate headquarters in Rancho Santa Margarita, California, and our European headquarters in Amersfoort, Netherlands with distribution centers around the world.
Applied manufactures surgical devices for a wide range of medical specialties. Each year, Applied dedicates, on average, 20% of our revenue to product development and projects that increase the efficiency of our manufacturing operations. As such, we are able to fuel the continuous development of new surgical technologies.
Applied is proud to have a significant and sustainable impact on healthcare. We address patient needs with advanced technologies that enhance surgical outcomes while also meeting our customers’ pressing economic needs.
Applied team members are part of one of the fastest growing and most progressive organizations in the healthcare field. We are proud to have a culture strongly committed to ethical business practices, mutual respect, teamwork, and caring about our customers and our community.
Applied's team members come from a wide range of experience, and their perspectives are crucial to the continued success of our organization. Applied respects each team member’s opinion and fosters a culture of open communication across all levels and departments.
We are looking for exceptional people who share in our mission to deliver breakthrough technologies that enhance surgical and clinical care. We seek creative problem-solvers from a variety of career paths and backgrounds who are interested in making a meaningful, positive difference.
https://appliedmedical.com/Legal/SocialMedia
Offices: 22872 Avenida Empresa, Rancho Santa Margarita, CA 92688, US · Wiekenweg 21, Amersfoort, Utrecht 3815 KL, NL · Queensland, AU · Seoul, KR · Beirut, LB
How many Engineering jobs are open in Amersfoort, Netherlands right now?
There are currently 106 open engineering positions in Amersfoort, Netherlands listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Amersfoort, Netherlands?
Companies currently hiring include Arcadis, Nscale, Eurofins Viracor, Applied Medical, KPN, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Amersfoort, Netherlands?
Yes — 59 of the 106 open engineering positions offer remote or hybrid work (8 remote, 51 hybrid).
How do I apply for Engineering jobs in Amersfoort, Netherlands?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.