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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.


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.


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.
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