Sensyne Health is hiring a

Regulatory Affairs Associate

Oxford, United Kingdom
Remote

About Us:

At Sensyne Health we combine technology and ethically sourced patient data to help people everywhere get better care. To do this, we have created a unique partnership with the NHS that delivers a return to our partner Trusts and unlocks the value of clinical data for research while safeguarding patient privacy. Alongside this, we develop clinically validated software applications that create clinician and patient benefit while providing highly curated data. Our products include vital-signs monitoring in hospitals and patient-to-clinician apps to support self-care and remote monitoring of gestational diabetes and chronic diseases such as COPD and heart failure.

We use our proprietary clinical AI technology to analyse ethically sourced, clinically curated, anonymised patient data to solve serious unmet medical needs across a wide range of therapeutic areas, enabling a new approach to clinical trial design, drug discovery, development and post-marketing surveillance.


The Role:

Within this role, you will be combining your knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. You will be providing your input and advice on changing regulations and guidance and will interface with outside regulatory agencies and trade associations. You will be joining a collaborative team ensuring that data is identified, obtained and effectively presented for the registration of products worldwide.


Responsibilities:

  • Assist in the preparation and submission of regulatory applications and registrations .
  • Evaluate regulatory risks of corporate policies.
  • 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..
  • Utilize 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.

Requirements

  • Experience in medical device regulatory affairs including knowledge of reporting and vigilance requirements in different territories, including 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


Bonus Skills

  • Knowledge of FDA Regulations
  • Experience of ISO 27001 standards

Benefits

  • Company share option scheme
  • 5% employer matched salary sacrifice Pension scheme
  • Life Assurance & Income protection
  • A range of health, wealth and lifestyle benefit plans including BUPA, Gym and holiday trade options
  • Electric Vehicle & Cycle to work schemes
  • Proactive career development planning