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, post market, you will be responsible for overseeing and coordinating all efforts associated with post market regulatory activities. 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

 

  • Ensure regulatory communications regarding complaint 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 statuses/progresses are tracked, and followed up
  • Review final letters to customers/ complaint submitters
  • Ensure regulatory communications regarding inquiries are handled appropriately
  • Monitor and ensure that European rules & regulations are being followed in all areas of the company
  • 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
  • 1+ years relevant working experience
  • Excellent oral and written communication skills in English
  • Knowledge of another European language is preferred
  • Knowledge of Quality Systems including ISO/CE marking is a plus

We Offer

  • Good remuneration package including pension and 27 vacation days
  • Travel allowance and health insurance benefits
  • Working from home option available
  • Opportunity for personal development and continuous learning
  • Education reimbursement program
  • Reimbursement of relocation expenses may apply
  • Informal and international work environment with over 35 nationalities
  • Teambuilding and volunteer opportunities
  • Onsite group exercise classes and health activities

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 recruitment-eu@appliedmedical.com or +31 (0)33 7548713.

 

Not the right job for you? Take a look at our other vacancies and follow us on LinkedIn.

 

As a healthcare company, it’s of the utmost importance to keep our teams safe and healthy in this ever-changing COVID-19 environment. We highly encourage our team members to get vaccinated to help protect each other, our families, our customers, and our visitors, as we work together to help end the pandemic.

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