We are currently seeking a highly motivated and experienced RA/QA Officer to join a dynamic and ambitious team in the medical device and pharmaceutical manufacturing industry.
- Take ownership of product documentation supporting safety and efficacy.
- Conduct regulatory assessments of changes and maintain up-to-date technical files and documentation history.
- Design and write summaries for regulatory compliance.
- Provide international regulatory support throughout the product life cycle.
- Coordinate the generation and maintenance of product dossiers and supporting documentation for registrations.
- Present and defend technical documentation during regulatory inspections and audits.
- Assist in complaint handling, root cause investigations, risk assessments, and CAPA management.
- Conduct internal audits and inspections as required.
- Bachelor's degree or similar experience in medical device or pharmaceutical manufacturing.
- Proven experience in the medical device or pharmaceutical industries.
- In-depth knowledge of applicable medical device regulations.
- Up-to-date knowledge of regulatory requirements and procedures.
- Strong technical writing ability.
- Excellent communication and presentation skills.
- Proficiency in Microsoft Office (Word and Excel).
A competitive salary and benefits package is offered, along with opportunities for professional growth. To apply, please apply via the link or for more info contact Aimee Brenner at firstname.lastname@example.org. We thank all applicants for their interest, but only qualified candidates will be contacted.