Company: Cortex-Dental
Location: Shlomi (North)
Department: QA/RA
Reports To: VP QA/RA
Job Description:
We are seeking an experienced Regulatory Affairs Specialist to join our team and contribute to the development, implementation, and management of regulatory processes within the company.
The ideal candidate will be responsible for communication with external regulatory bodies such as Notified body, EUDAMED, authorized representative. In addition will be responsible for analyzing and understanding regulatory requirements, providing guidance to various departments, executing regulatory registrations in multiple regions such as Asia, Europe north and south America and ensuring compliance with applicable regulations.
Key Responsibilities:
- Analyze and interpret new regulations in the medical device industry.
- Provide advice and guidance to internal teams on regulatory requirements.
- Develop and implement policies and procedures to meet regulatory standards.
- Conduct risk assessments.
- Represent the company in interactions with regulatory agencies and governmental bodies.
- Prepare reports and reviews on compliance status.
- Performing regulatory registration processes
If you are interested in joining a leading team in the regulatory affairs sector, please send your resume with the subject line "Regulatory Affairs Specialist Application."
We look forward to hearing from you!
Requirements: - Bachelors degree in Law, Business Administration, Life Sciences, or a related field.
- Minimum of 3 years of experience in medica device industry regulation.
- Previous submission experience of FDA, EU and other countries
- In-depth knowledge of regulatory frameworks and compliance requirements.
- Strong analytical skills and strategic thinking ability.
- Excellent interpersonal skills and ability to work collaboratively in a team.
- Proficiency in English
- Willingness to work in unconventional hours
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