Regulatory Affairs Associate

1 week ago

Crewe, United Kingdom Medtrade Products Limited Full time

We are seeking a highly motivated and detail-oriented Regulatory Affairs Associate to join our team. As a Regulatory Affairs Associate, you will play a crucial role in assisting with the preparation of regulatory submissions and supporting more senior members of the team to ensure regulatory approvals are obtained and maintained within project registration plans and the needs of the business. This is an exciting opportunity to contribute to the success of our company and make a difference in the lives of patients.
- Assist and support in the delivery of the global regulatory programme as required.Compile regulatory dossiers in accordance with national requirement for the approval of products, working to deadlines to ensure dispatch within agreed timescales.
- Assist in the monitoring of the progress of dossiers throughout the approval process, highlight issues to more senior team members
- To assist and provide support in completing the requirements of the global registration plan in line with business needs
- To assist and provide support to design change/change control assessments
- To assist in the review of artwork, labelling and promotional material and advise on its acceptability/compliance with regulations and registered details
- Develop understanding of regulatory legislation and guidelines.
- Assist in the creation and maintenance of Technical Files/Technical Documentation and other documents in line with regulatory requirements.
- Develop an understanding of the latest global regulatory requirements. Develop a working knowledge of individual country legislation
- To ensure the regulatory affairs filing system for paper documents including technical documentation is in audit ready condition.
- To organise translation of documentation
- To organise notarisation of documentation needed for RA submissions

**Education/Qualifications/Experience**

Higher degree in medical, biological or chemical sciences preferred.

Graduate level role where an understanding of the medical device regulatory framework would be an advantage.

**Competencies/Personal Skills/Behaviours**

An excellent verbal and written communicator to ensure understanding and guide to compliance of the regulations at all levels within the business.

Pragmatic approach to regulations and achieves compliance in the most efficient and timely manner.

Be a fully integrated and positive partner for the business units to drive regulatory submissions through to their ultimate approval.

Able to demonstrate a solution-focused approach.

Able to persuade and influence others.

Able to contribute and work effectively in matrix project teams.

Able to organise and project manage in a timely and effective way.

**Job Types**: Full-time, Permanent

**Salary**: £25,000.00-£26,000.00 per year

**Benefits**:

- Company pension
- Enhanced maternity leave
- Free parking
- Life insurance
- On-site parking

Schedule:

- Monday to Friday

Supplemental pay types:

- Yearly bonus

**Experience**:

- Regulatory Affairs: 1 year (preferred)

Work Location: Hybrid remote in Crewe

Reference ID: Regulatory Affairs Associate

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