Description
Regulatory Affairs (RA) Lead - Contract - Cambridge
An exciting opportunity has arisen for a Regulatory Affairs (RA) Lead to join a global Medical Devices company based in Cambridge. The client are offering an initial 8 month contract with a view to extend and can start the right Regulatory Affairs (RA) Lead ASAP.
DAILY DELIVERABLES:
- The creation & maintenance of high quality regulatory documentation, as needed for all classes of products.
- Responsibility for ensuring pre-market clearances are achieved in within set time frames.
- Management of the timely and precise adverse incident reporting processes, recall activities and other post marketing compliance activities.
- Responsiblility for follow up of Regulatory non-conformances.
- Lead key defined regulatory projects in order to support proportional risk based compliance projects together with an element of horizon scanning to build for the future.
- Build relationships and negotiate with relevant regulatory bodies on matters related to compliance of existing products and products undergoing development, and as appropriate support Business-2-Business teams.
- Accountable to ensure that devices remain in compliance with defined procedure and company policy.
- Consistently drive to create and implement new and innovative ways of doing things, demonstrates flexibility, open-mindedness, and adaptability to a rapidly changing environment.
- Drive regulatory processes, such as Regulatory Intelligence, MRL, Global Product Registration Requirements and Market Authorisations etc.
SKILLS/EXPERIENCE:
- Degree qualified in a relevant field ie. Science, Engineering, Life sciences, pharmaceutical, medical devices etc.
- 3 years Regulatory/Quality experience in medical devices. pharmaceutical, life sciences sectors.
- Experience dealing directly with Notified Bodies, Competent Authorities, and US FDA.
- Experience with managing a vigilance/incident system. Experience managing corrections and removals.
- Hands on experience of creating documentation compliant with EC Medical Devices Directive 93/42/EEC. FDA CFR 820 and RoW an advantage.
- Knowledge of compliance with key international standards such as ISO 13485 and ISO 14971.
- Demonstrate excellent communication skills.
- Demonstrated organisational, time management and proven leadership qualities.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercial.
- Strong critical and analytical skills with excellent judgment and decision making capabilities.
- Excellent team player and motivator.
Key Skills: Regulatory Affairs Lead, RA Lead, Regulatory Affairs Specialist, Pharmaceutical, Life Sciences, Medical Devices, Risk, Compliance, Validation, Verification, Contract.
We are currently speaking with candidates with a view to arrange interviews for next week. If this role could be of interest to you please send your latest CV to (see below) or call Deb Doyle at our Manchester office.
Key Skills: Regulatory Affairs Lead, RA Lead, Regulatory Affairs Specialist, Pharmaceutical, Life Sciences, Medical Devices, Risk, Compliance, Validation, Verification, Contract.
Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role. Key Skills: Regulatory Affairs Lead, RA Lead, Regulatory Affairs Specialist, Pharmaceutical, Life Sciences, Medical Devices, Risk, Compliance, Validation, Verification, Contract.