Applied Medical

Regulatory Affairs Specialist

Category (Portal Searching) Regulatory Affairs/ Quality
Job Locations NL-Amersfoort

Overview

Applied-Medical-Logo-w-Tag_H_Teal_cropped

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.

Job Description

Are you enthusiastic to build your career in regulatory affairs as a Specialist? We are looking for a driven Regulatory Affairs Specialist to join our Regulatory Team at Applied Medicals European headquarter located in Amersfoort (NL). As a Regulatory Affairs Specialist you will be responsible for overseeing and coordinating all efforts associated with regulatory documents and submissions. In addition, you will coordinate and handle the Applied Customer Experience Reporting process (CER) and ensure that effective reporting, trending, communication, and correct actions are taken. You will work closely together with various internal teams such as Customer Service, Quality, Sales, the Regulatory team in US and external customers.

 

The Regulatory Affairs Specialist reports to the Regulatory Affairs Manager.

 

Key Responsibilities

 

  • Monitor and ensure that European rules & regulations are being followed in all areas of the company
  • Maintain documentation of existing and emerging regulations, standards, and guidance documents
  • Ensure regulatory communications regarding complaint/MDR inquiries are handled appropriately, whether in response to an internal or external customer
  • Ensure all "reportable" events are reported on time to the European regulatory authorities and that status/progress is tracked, and followed up
  • Review final letters to customers/ complaint submitter
  • Ensures regulatory communications regarding inquiries are handled appropriately
  • Coordinate recall or market withdrawal activities when necessary
  • Assist with translation of the closing reports
  • Participates in formulation and establishing of quality standards
  • Assist with any other Regulatory duties such as product registrations, recall notifications, regulatory requests (both internal and external
    customers)

Requirements

  • Bachelor’s degree (HBO) in Regulatory or related field
  • 3+ years relevant working experience
  • Excellent oral and written communication skills in English
  • Knowledge of any other European language is preferred
  • Knowledge of Quality Systems including ISO/CE marking is a plus
  • Medical Device/ manufacturing/ regulatory experience is preferred

We Offer

  • Good remuneration package including pension and 27 vacation days
  • Travel allowance and health insurance benefits
  • Opportunity for personal development and continuous learning
  • Education reimbursement program
  • An informal and international work environment with over 35 nationalities
  • Teambuilding and volunteer opportunities
  • Onsite group exercise classes and health activities
  •  

Interested?

 

Are you an individual who thrives in a fast-paced, challenging, and professional, yet casual business environment? We are looking forward to receiving your application. For more information regarding our hiring process, click here.

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