Quality & Regulatory Associate, Challenging Global

vor 5 Monaten

Basel, Schweiz Stratpharma Vollzeit

An ambitious forward thinking Dermatology company based in the centre of Basel have created an exciting hybrid QARA Associate opportunity that will work closely with the International QARA Director in managing the company’s global QA and RA functions.

This is a highly successful company who have an impressive 200% year on year growth and are going through significant expansion. They currently have 8 products on the market but have a further 5 more products in development, one of which will be released early next year.

**Tasks**:

- Creation, compliance and/or implementation of SOP, Work Instructions, Non-Conformities, Change Control, CAPA, Artworks, and all related document and tasks.
- Maintain and update all the documents in the companies system.
- Provide support for Internal and External Audit.
- Initiate and review regulatory documents (e.g. Technical file) giving support to the Regulatory Manager with the transition from MDD to MDR.
- Coordinate worldwide registration and compile regulatory submissions, including required legalization activities.
- Liaise with local agents and distributors to support them in their registration process.
- Maintain regulatory records and regulatory database.

**Requirements**:

- 3 plus year’s experience in a similar role.
- Strong knowledge of regulatory regulations and Quality Systems including knowledge of ISO13485, MDD, MDR and MDSAP requirements in link with QMS activities.
- Experience of the Medical Device or Pharmaceutical industry.
- Proactive self-starter who can work autonomously.
- Strong communication skills with the ability to liaise effectively with stakeholders, suppliers and distributors.
- Fluent in written and spoken English essential, Spanish an advantage.

**Benefits**

This is a newly created role in a rapidly growing company that offers career boosting global exposure. The company has a friendly family culture and maintains a high level of staff retention.

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