Regulatory Affairs Specialist
hace 1 día
**Job Summary**
Empresa Reconocida is seeking a highly skilled Regulatory Affairs Specialist to join their team in Barcelona. As a key member of the Regulatory Affairs Team, you will be responsible for ensuring regulatory requirements are met for new product development and design changes to established legacy devices.
**Key Responsibilities:**
- Prepare technical documentation and submission packages for global regulatory submissions.
- Establish and maintain regulatory information systems, technical documentation files, and routine reports.
- Collaborate with global Regulatory Affairs teams to understand existing and/or new regulatory requirements and guidelines.
- Ensure regulatory compliance to global requirements and company policies.
- Support new product development activities and review documents and product changes for regulatory submission impact.
- Liaise with the vigilance team regarding product dossiers and post-marketing activities.
- Assist with inspections and audits.
**Requirements:**
- 1 year of experience in Regulatory Affairs within a Medical Device or Aesthetics organization.
- Working knowledge of the Medical Device Regulation and Medical Device Directive.
- Excellent attention to detail and strong written and oral communication skills.
- Fluency in written and spoken English.
**What We Offer:**
A dynamic and challenging work environment with opportunities for growth and development.
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