An ambitious forward-thinking Dermatology company has created an exciting hybrid QARA Associate opportunity to manage global QA and RA functions closely with the International QARA Director.
This successful company boasts 200% year-on-year growth and is undergoing significant expansion, with 8 products on the market and 5 more in development, including one set for release early next year.
Key Responsibilities:
* Develop, maintain, and implement SOPs, Work Instructions, Non-Conformities, Change Control, CAPA, Artworks, and related documents and tasks.
* Ensure accurate maintenance and updates of all company documents within the system.
* Provide support for internal and external audits.
* Initiate and review regulatory documents (Technical files) while assisting the Regulatory Manager with transitioning from MDD to MDR.
* Coordinate worldwide registration and compile regulatory submissions, including legalization activities.
* Liaise with local agents and distributors to facilitate their registration process.
* Maintain regulatory records and databases.
Requirements:
* At least 3 years of experience in a similar role.
* Strong knowledge of regulatory regulations and Quality Systems, including ISO13485, MDD, MDR, and MDSAP requirements in relation to QMS activities.
* Experience in the Medical Device or Pharmaceutical industry.
* A proactive self-starter who can work autonomously.
* Excellent communication skills with the ability to liaise effectively with stakeholders, suppliers, and distributors.
* Fluent written and spoken English; Spanish is an advantage.
Benefits: