דרישות התפקיד וניסיון נדרש:
1. Preparing and maintaining regulatory documentation.
2. Responsibility for implementing regulatory requirements in accordance with EU MDR 2017/74 and FDA medical device regulation.
3. Conduct regulatory assessments, mostly related (but not limited) to qualification of production site.
4. Participate in risk management activities and perform benefit-risk assessments.
5. Maintaining technical documentation including submission to applicable authorities.
6. Providing regulatory support for validation and verification process.
7. Meet project timelines, including communicate project status to stakeholders.
8. Work in collaboration with the various company sites departments such as: R&D, Quality, Engineering, Operations, and Marketing, as well as external regulatory partners.
- Education: at least BA in life Sciences, chemistry, biochemical or biomedical field, or any other of relevance.
- Excellent English skills, including speaking, writing, and reading skills.
- Minimum 2 years of regulatory and medical device experience.
- Excellent interpersonal skills and abilities to work as a team member in a global environment.
- Strong analytical and problem-solving abilities
- Personal qualities: A diligent, organized, understanding and oriented character.
- Self-Motivated - Autodidact
