Notice: Undefined index: HTTP_ACCEPT_LANGUAGE in /home/www/live/www.israemploy.net/www/inc_languageFunctions.php on line 18
Israemploy - Jobs in Israel Network, לוח דרושים
Home Page Add to your favorite sites Contact Us Tell A Friend
 
 
 
Job Search
 
Become a Member
 
Log In
 
 
Get latest jobs
Post A Job Job Networking FAQ
  israemploy Jobs in Israel Network  
Latest News  

Job Opportunity: Senior Regulatory Affairs Specialist

 
Date   Dec 11
 
Listing No.   IE245485
 
Sector   Medical & Healthcare
 
Region   Center
 
City/Yishuv   Ramat Gan
 
 
Senior Regulatory Affairs Specialist
 
For a dynamic start-up specializing in the design, development, and manufacturing of innovative medical devices for inhalation of plant substances. We’re looking for a Sr. Regulatory affairs specialist to join our team and support the development and implementation of the company’s regulatory effort.
As a Sr. Regulatory affairs specialist you will be responsible for the approval and registration process of the company's products in liaison with all relevant regulatory authorities around the world.

Responsibilities:

Gathering, evaluating, organizing and managing information required for submission dossiers both for Medical Device and Pharmaceuticals Regulatory Bodies, worldwide.
Developing and writing clear rationales and summaries for new submissions and license renewals, as well as for internal documentation.
Ensuring compliance with regulations prescribed by relevant regulatory authorities.
Keeping up to date with changes in regulatory legislation and guidelines.
Liaising and negotiating with regulatory authorities.
Assisting in preparation and maintenance of pharmacovigilance documentation, including reporting.
Outlining requirements for labeling and packaging.
Supporting QA department activities as needed.

Requirements

Relevant degree in life or medical sciences.
Minimum 5-8 years of experience in regulatory affairs from the pharmaceutical (preferred) or medical device industry (combination devices - preferred).
Clinical regulatory working experience
Close familiarity with European, Canadian and US drug and medical device regulations. (FDA submission experience-strong advantage).
Familiarity with quality system regulations, GMP and ISO 13485.
Mother tongue level English.
Excellent writing skills.
Ability to work both independently and in a team.
 
 
To apply for this and many other job opportunities paid membership is required Register Now. If you are already a member Login.
“This is the only website I ‎recommend for English speaking job seekers” (Nessa, Tel Aviv)
     
 
 
REPORT A PROBLEM
Built by Fine Websites