Job Title: Regulatory Affairs Officer
Location: Oxford, England
Job Type: Permanent
A growing medical technology company is seeking a Regulatory Affairs Officer to support regulatory compliance and documentation activities. This role will report directly to the Regulatory Affairs Manager and assist in maintaining regulatory submissions, product registrations, and compliance documentation.
Key Responsibilities
Working under the guidance of the Regulatory Affairs Manager and/or Global Labelling and Compliance Manager, the Regulatory Affairs Officer will:
* Update and maintain regulatory documentation to ensure compliance with industry regulations.
* Assist in compiling and organizing materials required for regulatory submissions.
* Collaborate with cross-functional teams to collect necessary data for regulatory change submissions.
* Support the submission process for regulatory changes, track responses, and provide additional information as needed.
* Aid in the maintenance and creation of product registrations and certifications.
* Assist with data gathering and analysis for Post-Market Surveillance reporting.
* Maintain regulatory information within the company's Regulatory Information Management Software (RIMS).
* Provide training on the RIMS platform for new and existing employees.
* Support the maintenance of technical file documentation and product labeling.
* Assist during regulatory audits conducted by notified bodies.
Required Skills & Experience
* Strong attention to detail.
* Proficient scientific writing skills.
* Excellent organizational abilities.
* Experience in the medical device industry in a quality or regulatory role.
* Knowledge of ISO 13485:2016 quality management system.
* Experience managing regulatory documentation and submissions (preferred).
* Familiarity with medical device registrations in the EU/UK (preferred).
* Ability to thrive in a fast-paced and evolving environment.
This role offers an opportunity to be part of a dynamic team working on cutting-edge medical technology while ensuring compliance with global regulatory requirements.
Please reach out to emily.james@skillsalliance.com for further information.