Job Title: Senior Regulatory Affairs Professional (RA)
Location: FULLY REMOTE
Status: Full time, Permanent.
Salary: 65k + Benefits- company share option scheme, 5% employer matched salary sacrifice Pension scheme, Life Assurance & Income protection, range of health, wealth, and lifestyle benefit plans (gym membership & holiday trade options for example) and more.
Do you want to work with a company that contributes to solving health-care's biggest challenges, by valuing clinical data and unlocking the next generation of medical discoveries? If so, this may be the role for you....
This senior remote role will require you to combine your skills and knowledge in scientific, regulatory, and business issues to enable products are developed, manufactured, or distributed to meet required legislation. Although you will work remotely, you will be part of a collaborative team ensuring that data is identified, obtained, and effectively presented for the registration of products worldwide. You will be part of an innovative digital health company who is currently expanding to Europe and the States and creating significant differences to global health!
- Must assist in the preparation and submissions of regulatory applications and registrations and evaluate regulatory risks of corporate policies.
- Will need to assist in the preparation and submission of regulatory applications and registrations.
- Must work across both regulatory and quality functions ensuring advice and insight, and support employees from other teams when needed.
- Will regularly work with internal and external regulatory agencies as well as notified bodies and trade associations.
- Utilise technical regulatory skills to advise on MDR implementation and will need to help regulatory affairs in product recall and recall communication process.
- Assist in maintaining annual licenses, registrations, listings, and patent information and assist in the development of relevant data to complete regulatory submissions.
- Experience in medical device regulatory affairs, including knowledge of working in different territories- particularly the US.
- Knowledge of applicable standards ISO 13485.
- Ability to work independently due to the position being remote, must also be able to work as a team.
- Be able to plan and manage workload.
- Excellent written and verbal communication skills.
- Knowledge of FDA regulations
- Experience of ISO 27001 standards.
- Knowledge of pharmaceutical regulations
Life Science People has a vast international network within the life sciences. We recruit at all stages of the drug development cycle, this means we can deliver bespoke, industry specific, services to all our clients and candidates.
So, what's next?
All successful CVs will be contacted within 24 hours, if screening is successful, these CVs will then be passed on to my client for interview.
For any queries please email:
Apply today to not only grow your career but, also to make a tangible difference to global health!