Regulatory Affairs Specialist II - Remote
Full-Time | 37.5 Hours per Week
My client is a leading provider in the diagnostics industry, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing. Their work provides critical information for the treatment and management of diseases and other health conditions.
We are currently seeking a Regulatory Affairs Specialist II within the Infectious Disease business unit. In this role, you will be responsible for preparing documentation for international product registrations.
Responsibilities:
* Prepare technical documentation in accordance with In Vitro Diagnostic Medical Device Regulation (IVDR).
* Provide regulatory support for diagnostic product development and commercial diagnostic products.
* Perform regulatory impact assessments to ensure compliance with international regulations and timelines.
* Coordinate with internal and external stakeholders to gather necessary information.
* Maintain up-to-date knowledge of regulatory changes and industry standards.
* Develop regulatory strategies for new and modified products to achieve international clearance/approval.
* Support regional regulatory teams with submissions, license renewals, and amendments.
* Research and communicate scientific and regulatory information to support submission documents.
* Compile and publish all material required for submissions, renewals, and annual registrations.
* Maintain approvals/licenses/authorisations for existing marketing authorisations.
* Assess product, manufacturing, and labelling changes for regulatory impact and compliance.
* Develop internal procedures and tools to enhance regulatory processes.
* Conduct informational or training sessions for stakeholders.
* Organise and maintain both hard copy and electronic department files.
* Demonstrate commitment to the development and effectiveness of the company's Quality Management System per ISO, FDA, and other regulatory agency requirements.
* Exhibit professionalism with internal and external business associates in alignment with company policies.
Basic Qualifications | Education:
* Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering, or a related technical field, or equivalent experience.
* 4+ years of experience in a Regulatory Affairs role.
* Strong knowledge of IVDR, EU, and international regulatory requirements.
Preferred Qualifications:
* 1+ years of experience in an IVD or medical device manufacturing environment.
Competencies:
* Strong knowledge of EU and international regulations.
* Excellent written and verbal communication skills.
* Strong time management skills with the ability to manage multiple projects simultaneously.
* Ability to work both independently and within a team.
* Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Visio.
How to Apply:
To apply, please click the button or contact Danielle at 01489 336283.
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