Overview
Quality & Regulatory Associate Jobs in Basel, Kanton Basel-Landschaft, Switzerland at TN Switzerland
Position: Quality & Regulatory Associate, Challenging Global Role
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Quality & Regulatory Associate,
Challenging
Global Role, Basel Client:
Stratpharma AG
Location:
Basel
Job Category:
Other
Job Reference:
0
Job Views:
1
Posted:
17.04.2025
Expiry Date:
01.06.2025
Job Description:
An ambitious forward-thinking Dermatology company based in the centre of Basel has 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 that has an impressive 200% year-on-year growth and is going through significant expansion. They currently have 8 products on the market and 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 documents and tasks.
Maintain and update all the documents in the company’s system.
Provide support for Internal and External Audits.
Initiate and review regulatory documents (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 years’ experience in a similar role.
Strong knowledge of regulatory regulations and Quality Systems including knowledge of ISO
13485, MDD, MDR, and MDSAP requirements in link with QMS activities.
Experience in 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 is an advantage.
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Title: Quality & Regulatory Associate
Company: TN Switzerland
Location: Basel, Kanton Basel-Landschaft, Switzerland
Category: Healthcare (Data Scientist), Quality Assurance – QA/QC
