Offre d'emploi : Regulatory Affairs Manager
Founded in 2009, CryoTherapeutics is an early stage European innovative company that is now establishing its operations in Awans (Liège). The company is in the process of developing a novel catheter system to treat atherosclerotic plaque that causes heart attacks by delivering cryoenergy to the coronary arteries. For additional information about the company, please visit http://www.cryotherapeutics.com/
CryoTherapeutics aims to develop and market the novel cryoenergy therapy initially for patients who have suffered a heart attack, and in the longer term also for patients identified as being at future risk of heart attack. CryoTherapeutics recently raised 7M€ in its latest round of financing and will use these funds to continue development of this technology with the aim of starting clinical studies later this year.
In order to support the expansion of the team in Liège, we are looking for a (m/f):
Regulatory Affairs Manager
As Regulatory Affairs Manager, you are in charge of writing the technical documentation to support clinical study applications, CE marking and FDA registration. You insure compliance of product technical files with regulatory standards and provide support to ensure that regulatory standards are part of the Product Development Process.
Your main responsibilities are:
- Write technical documentation including Investigator Brochures, Clinical Protocols, Product Risk Analysis, Biocompatibility Risk Assessments.
- Prepare technical files for Clinical Studies filings, CE-Mark applications and FDA registrations.
- Maintain technical documentation to ensure compliance with internal QMS and Regulatory Standards.
- Support R&D and Manufacturing to define the product/process validation strategies in compliance with Regulatory Standards.
- Ensure that normative and regulatory changes are identified in a proactive manner and coordinate actions plans.
- Manage product registration processes.
- Report work evolution on a regular basis.
- Master’s degree or Ph.D. degree in Science or equivalent through experience.
- 5 to 10 years’ experience in Regulatory Affairs for Class II & III Medical Devices.
- Strong technical writing skills (Investigator Brochures, Clinical Study Protocols, Risk Management).
- In-depth knowledge of regulatory requirements, MDR’s and EU ISO regulations and US FDA Quality System Regulations 21 CFR Part 820 and Part 11 (preferred).
- Excellent interpersonal, communication and presentation skills.
- High level of attention to detail, excellent organizational skills and time management, flexibility.
- Fluent in English, written and spoken. Knowledge of another language is an asset.
- Willing to travel abroad occasionally.
- A challenging position with a high potential innovative and young medical device company.
- To work in a human-sized, collaborative and respectful environment
- Work within a dynamic and experienced team that brings the best out of motivated potentials.
- An attractive compensation package in line with the position’s responsibilities and your experience
Please send your CV together with an adapted cover letter http://www.pahrtners.be/job/regulatory-affairs-manager/ or to email@example.com
Your application and related information will remain strictly confidential.