Applied Medical

Regulatory Affairs Manager Medical Devices

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

Overview

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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 for 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

As Regulatory Affairs Manager you provide guidance regarding compliance with European regulations and lead the Regulatory Team. You are the crucial link between Applied Medical, our medical device products and the regulatory authorities. In this dynamic position within our vertically integrated company, you will contribute to MDD compliance and contribute to MDR readiness. The advice the Regulatory Affairs team provides coordinates the approval and post-market surveillance of our products.

As Manager Regulatory affairs you will report to the VP Operations. 

 

Within Applied Medical this position has the internal job title of Regulatory Affairs Manager.

 

Key Responsibilities

  • Provide, as a subject matter expert, regulatory oversight and guidance to teams in the organization on compliance matters and other competent authority requirements including, but not restricted, to MDD and MDR
  • Support and manage a team of 5 to improve their individual and team performance, including performance reviews/appraisals
  • Manage complaint handling and coordinate field safety actions
  • Facilitate audits and inspections by regulatory agencies
  • Review and approve technical and production-related technical documentation, also to support sales and tender activities
  • Review recurring regulatory-related processes
  • Monitor the production worksurface bioburden process
  • Act as subject matter expertise on the sterilization process of medical devices
  • Manage additional local regulatory submissions and communicate with regulatory authorities and distributors
  • Understand and follow Applied Medical’s Quality Systems (QS), environment health and safety (EHS) rules and company policies

Requirements

  • Bachelor, master or a higher scientific degree
  • At least 5 years’ experience in regulatory affairs, preferably in medical devices
  • A minimum of 3 years’ experience in a comparable leadership position
  • Knowledge of Medical Device regulations (MDD, MDR)
  • Previous participation in preparing Regulatory submissions to EU Regulatory Authorities.
  • Knowledge of quality systems and standards in a highly regulated environment
  • Experience in writing, reviewing and approving technical documentation
  • Proficient level of English, spoken and written

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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