Regulatory Affairs Specialist

Regulatory Affairs Specialist

Applied Medical

Amersfoort, Netherlands

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.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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