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DemeTECH is seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory guidance, and managing submissions to regulatory bodies.
Responsibilities:
Education: Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.
Communication skills: Good technical capabilities, communication skills, teamwork abilities and initiative
Technical Proficiencies: Regulatory Affairs Certification (US or EU) preferred. Proven ability to work well as part of a team & on own with minimum supervision. Working knowledge of FDA and other regulatory authorities with experience supporting compliance.
Experience: 6-8 years of experience in Regulatory Affairs, including preparation of submissions to the FDA/EU. A minimum of 6 years of experience in medical device, drugs, biologics, and/or combination products, preferred
Full Time
Medical Technology
$86k-110k (estimate)
06/01/2024
06/28/2024
demetech.us
MIAMI LAKES, FL
25 - 50
2000
Private
LUIS H ARGUELLO
$10M - $50M
Medical Technology
DemeTech is a manufacturer and supplier of absorbable, non-absorbable sutures and needles for the healthcare industry.
The job skills required for Senior Regulatory Affairs Specialist include Regulatory Affairs, Product Development, Initiative, Quality Assurance, Collaboration, Communication Skills, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Regulatory Affairs Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Regulatory Affairs Specialist. Select any job title you are interested in and start to search job requirements.
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