Safety Officer & Regulatory Specialist - Flexible Working Available
At Roche Diabetes Care we have an exciting opportunity for an experienced Safety Officer & Regulatory Specialist to join our team in Burgess Hill, West Sussex.
In this role you will ensure Roche Diabetes Care UK Ltd meets Medical Device Regulations. You will be responsible for:
- Product Registrations, Maintenance and Extension
- Carrying out Medical Device Post Market Surveillance
- Early identification & trending of Product Complaints
- Maintaining regulatory relationships with the external agencies
- Managing key relationships with internal parties, Safety Boards, GSS and Business Areas with respect to product safety
- Management of the communication of safety issues including company product bulletins and notices
- Co-ordinate with respective business areas to keep abreast of new/changes to products and process developments effecting safety
- Ensuring that there are adequate processes to monitor and contribute to the progress of all safety cases, including communications with the Regulatory Authorities, customers and implementation of corrective and preventative actions
For this role you will bring:
- University Degree or equivalent
- Previous proven experience working for an international company in Quality/Regulatory operations
- Proven experience working directly with Registered Bodies and the MHRA/HSE
- Highly organised with proven strong communication skills at all levels
- Proven ability to influence and drive change
- Self-motivated with a passion for achieving results
- SAP experience advantageous
- Experience working with the Google suite of programmes
- Flexibility to travel – this role may require some travel
If you want to work with an award winning global company that is, like you, ambitious, determined and innovative, this is a fantastic opportunity. We have a fun, fast paced, dynamic culture which offers support and encouragement where all new ideas are welcomed with opportunity to bring your ideas to life.
Closing date: 20 December 2019
Who we are
Roche Diabetes Care has been a pioneer in providing innovation in diabetes technology and services for more than 40 years, helping people with diabetes to live their lives as active and unrestricted as possible. The Accu-Chek brand, in collaboration with partners offers people with diabetes and healthcare professionals, innovative products and impactful solutions to deliver personalised diabetes care and improve therapy outcomes.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.