Do you want to work for a company that has a unique offering in artificial intelligence? Would you like to work in an environment where your work can improve patient care and address unmet medical needs through the analysis and commercialisation of real-world evidence? If so, this may be the role for you.
We are looking for a Regulatory Affairs Associate to join a growing and collaborative team, providing input and advice on changing regulations and guidance and working with outside regulatory agencies. Within this role, you will be combining your knowledge of scientific, regulatory and commercial business issues to enable products that are developed, manufactured or distributed to meet required legislation.
Reporting to the Head of Regulatory Affairs, your role will include:
- Assist in the preparation and submission of regulatory applications and registrations.
- Provide input for product development and planning throughout the product lifecycle.
- Assist in correspondence with review agencies, notified bodies, and trade associations on matters relating to product registrations and PMS.
- Utilise technical, regulatory skills to advise on MDR implementation.
- Work across Regulatory and Quality functions, ensuring timely advice and insight.
- Help regulatory affairs in product recall and recall communication process.
- Assist in maintaining annual licenses, registrations, listings and patent information.
- Liaise internally and externally with regulatory agencies
- Create project plans and timelines.
- Assist in the development of relevant data to complete regulatory submissions.
- Write and edit technical documents.
- Evaluate the regulatory risks of corporate policies.
Skills and Experience Required:
- Experience in medical device regulatory affairs including knowledge of reporting and vigilance requirements in different territories, including the USA
- Knowledge of applicable standards ISO 13485
- Detail-oriented and excellent written and verbal communication skills
- Ability to work independently
- Ability to plan and manage workload
- Strong interpersonal skills and the ability to work as part of a team
- Ability to support employees from other teams
- Knowledge of FDA Regulations
- Experience of ISO 27001 standards
- Experience with pharmaceutical regulations
If this role interests you, then please apply now. You can submit your CV and cover letter highlighting your expertise as a Regulatory Affairs Associate. We will send you a confirmation of acknowledgement, and please note feedback can take up to 2-3 weeks. Upon successful selection for an interview, the process will occur in the following three stages:
First stage: This will be an initial screening call with a Life Science People representative
Second stage: An initial phone call with the hiring manager - Head of Regulatory Affairs to go through background and experience in relation to the role
Final Stage: This will be a final interview with key stakeholders within the business and may require a short presentation
The Regulatory Affairs Associate role is a full-time permanent position, paying up a competitive salary & benefits package. You will be based remotely from home even when the restrictions lift. Full details will be provided on application. In addition to a generous basic salary, the company offers the following benefits package:
- Company share option scheme
- 5% employer matched Pension scheme
- Life Assurance
- A range of health, wealth and lifestyle benefit plans including BUPA, Gym and holiday trade options
- Cycle to work schemes
- Proactive career development planning
- Income Protection