RA Specialist
RA Specialist
09/04/2025RA Specialist is responsible for supporting and executing the company regulatory & compliance strategy.
The RA Specialist will assist the organization in ensuring regulatory compliance with established standards/guidance and implementing procedures to ensure that the business unit’s regulatory program is effective and efficient. In his/her main role, the RA Specialist will lead the qualification of a new production site and will be responsible for site regulatory compliance with both EU and US regulations.
To qualify the new oversea manufacturing location, the RA Specialist will collaborate with R&D, Quality, Engineering, Operations, and Marketing departments daily to ensure alignment with commercial and regulatory requirements. In addition to the above main role, the RA specialist will support day to day regulatory operations including conducting regulatory assessment, preparing regulatory submissions, and reviewing critical documents to determine applicability and acceptability for regulatory submission.
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