Senior Medical Writer – Medical Devices

ROLE OVERVIEW

We are currently looking for an experienced Medical Writer to join our client’s team to support a specialist regulatory project within the medical device sector. This exciting contract opportunity is fully remote and open to professionals based across Europe, supporting the preparation of a forthcoming FDA submission.

Working at the centre of a high-impact regulatory programme, you will help develop, review, and strengthen key documentation for an innovative medical device technology. You will collaborate closely with cross-functional stakeholders to ensure submission materials meet high standards and align with FDA expectations.

KEY DUTIES AND RESPONSITIES

Your duties as the Job Title will be varied however the key duties and responsibilities are as follows:

• Support the preparation of an FDA submission by reviewing and refining technical and clinical documentation to ensure it is fit for regulatory use.
• Review technical and clinical documentation to assess suitability for FDA submission, identifying gaps, risks, and inconsistencies.
• Collaborate with stakeholders to resolve documentation issues and strengthen the submission package through clear, actionable recommendations.
• Review and provide input on clinical study protocols and related documentation that support regulatory submissions.
• As the Job Title you will address regulatory feedback and ensure documentation meets required standards prior to submission.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the Job Title we are looking to identify the following on your profile and past history:

• A Degree or higher level in a relevant field (e.g., life sciences / biomedical / pharmaceutical) or equivalent demonstrable expertise in medical writing.
• Demonstrated experience in medical writing within the medical devices sector, including preparation and review of submission documentation.
• Strong understanding of FDA regulatory requirements and submission processes, with the ability to assess documentation quality against expectations.
• Proven ability to work independently, identify risks and inconsistencies, and communicate recommendations clearly in a remote environment.

WHAT’S IN IT FOR YOU?

• Fully remote contract opportunity, with flexibility for professionals based in Europe.
• High-impact, project-focused work supporting a forthcoming FDA submission for novel medical technology.
• Opportunity to collaborate with cross-functional stakeholders and contribute to documentation that directly supports regulatory decision-making.
• A role that values clear communication, independent judgement, and stakeholder engagement.

Key Words:

Medical Writing / FDA Submission / Medical Devices / Regulatory Documentation / Clinical Documentation / Risk Identification / Stakeholder Collaboration / Clinical Protocol Review / Remote Working

"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career".

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.