Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist.

Senior Regulatory Affairs Specialist

Eindhoven

|

€60000 - €90000 per year

|

Permanent

|

Regulatory Affairs

To Apply for this Job Click Here

Join a Medical Device company making a real difference!

Title: Senior Regulatory Affairs Specialist

Reporting To: CMO

Industry: Life Sciences - Medical Devices

At Darwin Recruitment, we are excited to be partnered with a leading medical technology company focused on cutting-edge neurotherapies. Recognized by the United States Food and Drug Administration (FDA) with Breakthrough Device Designation, they are committed to accelerating access to life-changing treatments.

Position Overview:

We are helping this company recruit an experienced Regulatory Affairs Specialist to play a pivotal role in their cross-functional team. Reporting directly to the Chief Medical Officer, you will drive the regulatory strategy, ensuring compliance across international markets. Collaborating closely with regulatory consultants, you will refine the approach to meet global requirements. Your expertise will guide this company through FDA and CE-marking processes, facilitating successful product launches and ongoing compliance efforts.

Your Responsibilities:

Your responsibilities include but not limited to the following:

  • Develop and execute regulatory strategies for FDA and CE-marking approvals, maintaining compliance throughout product lifecycle.
  • Serve as primary liaison for regulatory submissions and communications with Competent Authorities, FDA, and Notified Body.
  • Coordinate preparation and submission of regulatory documents.
  • Provide regulatory support for post-market surveillance activities, including adverse event reporting.
  • Stay updated on regulatory changes and standards impacting our products.

Your Profile:

  • Academic background in relevant field (e.g., science, medicine, pharmacy) with a passion for medical technology.
  • Minimum 5 years' experience in medical device regulatory affairs, preferably with active implantable devices.
  • Proven track record of obtaining regulatory approvals in EU and/or USA.
  • Strong analytical and writing skills, with a proactive approach to tasks.

Please apply or email james.allen@darwinrecruitment for more information.

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.

James Allen

To Apply for this Job Click Here

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