Quality and Regulatory Affairs Manager

17-10-2018 zaventem
description de la société

With approximately 50.000 employees worldwide, we help pharmacies, hospitals and ambulatory surgery centers, clinical laboratories and physician offices focus on patient care while reducing costs, enhancing efficiency and improving quality.

Do you have experience with developing and implementing regulatory strategies and processes? Do you have a first experience with Quality? If this speaks to you, this could be your next big adventure!

Just apply here for this challenging opportunity: laurence.teerlynck@cx.ausy.be or 03 200 28 01.

description de la fonction

Do you have experience with developing and implementing regulatory strategies and processes? Do you have a first experience with Quality? If this speaks to you, this could be your next big adventure!

Develop and implement regulatory strategies and processes to assure timely commercialisation of products in compliance with applicable regulations and standards in country

- Execute quality and regulatory processes at EMEA level
- Guarantee that regulatory requirements are met in regards to national laws and company standards in order to place and/or maintain products at the EMEA level and for countries under his/her area of responsibility
- Act and/or supervise as Local Safety Officer for local authorities under his/her area of responsibility
- Act as Management Representative at the country level
- Execute quality processes
- Execute regulatory processes
- Ensure regulatory and quality training and assessments for Sales & Marketing Department and for any other concerned employees
- Approves processes and changes CO’s pertaining to the Manager’s projects and dutiesat the EMEA level
- Clinical Studies application and Serious Adverse Events reporting occurring in clinical studies to Competent Authority(ies) in EMEA as necessary.
- Manage subordinate staff
- Support record Retention appropriately

vos atouts

- Consistent background and knowledge of MD regulations
- Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, local regulatory body Device Law/Regulations, World Wide Regulatory Requirements/Procedures, Project Management, and Negotiations
- Relations established with the key interlocutors in the network of the MDs (e.g., regulatory agencies, professional organizations, etc.)
- Ability to identify early the risks incurred by the company, to make the necessary warnings and propose appropriate action plans, in agreement with the Quality Assurance and Regulatory Affairs Director
- Ability to work in team and to share experiences
- Good communications skills, including English

qu'offrons-nous?

As an answer to your high performance & flexibility, Ausy offers you an interesting salary package, with some nice extra's like:

- Meal vouchers of €7
- Net representation cost of €50
- hospitalization insurance
- Car + fuel card OR home-work compensation
- 32 holidays
- End-of-year bonus
- Pension plan
- ECO vouchers
- Opportunities to follow trainings

sommaire
fonction
chef de projet / manager (m/f)
type de job
temps plein, freelance
type contrat
jobs fixes immédiat
référence
CXRSP-73994
informations de contact
Laurence Teerlynck
laurence.teerlynck@cx.ausy.be 03 201 39 26
03 201 39 26