Regulatory Affairs Specialist, Pre Market

Applied Medical

  • Amersfoort, Utrecht
  • Vast
  • Voltijds
  • 23 dagen geleden
Job Description:Are you a collaborative RA Specialist that enjoys working on projects involving different departments?Does working in the Head Office of one of the most progressive Medical Device Manufacturers sound exciting?We have an inspiring opportunity for you in Amersfoort (NL) as our driven Regulatory Affairs team at Applied Medical’s European headquarters is looking for a proactive and communicative Pre Market Specialist.As one of our Specialists, you will be compiling technical files and supporting submissions and certification efforts in different European regions.To ensure market access activities are carried out in compliance with set standards and medical device regulations, you will work closely together with various internal teams, such as Product Management, Quality, Sales, Legal, the Regulatory team in the US and external stakeholders.To succeed, you bring in solid project management and administrative skills and the ability to communicate with professionals with different backgrounds, roles and priorities.This role is based at European headquarters in Amersfoort (NL) and reports to the Team Leader Regulatory Affairs, Pre Market.Key Responsibilities
  • Initiate and manage regulatory activities related to product changes or new product introductions
  • Collaborate with different departments and stakeholders to communicate applicable regulatory requirements and provide support
  • Own and manage technical product documentation: prepare, submit, update and maintain technical files in the supported regions
  • Assist in communication with certifying bodies, external stakeholders and competent authorities
  • Develop in-depth knowledge of relevant laws and regulations (region and country specific)
  • Monitor and promote compliance with European standards, rules and regulations
What you bring
  • Bachelor’s degree (HBO) in Engineering, Medical Affairs or Regulatory Affairs related field
  • At least 1 - 2 years experience working within or in close contact with Regulatory Affairs or Engineering teams
  • Experience in a highly regulated business, creating technical files
  • Experience in Medical Devices, knowledge of Quality Management Systems, ISO or CE mark is a plus
  • Excellent oral and written communication skills in English
  • Eligible to work in the Netherlands
  • Experience in an international environment is a plus
What we offer
  • Permanent contract
  • 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 an NS Business card subscription
  • 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 . If you have any questions, feel free to contact us via TA-Europe@appliedmedical.com or +31 (0)33 7548713

Applied Medical