Regulatory Affairs Assistant/Officer, Career Development Guaranteed, Basel
Stratpharma AG
Basel, Basel-Stadt, Switzerland
vor 17 Tg.

Description

A small life sciences company in Basel with impressive year on year growth have identified the need for a Regulatory Affairs Assistant / Officer with medical device exposure to help them move to the next level in their development.

This company have both Pharmaceutical and Medical Device products that they release globally. This role offers a unique opportunity for career development.

The company have recently secured significant investment and this is an opportunity to get in at the ground floor of a company really beginning to take off.

Tasks

  • Assist the Regulatory Affairs Manager for worldwide registration
  • Coordinate and compile regulatory submissions, including preparation and maintenance of Free Sales Certificates and required legalization activities
  • Liaise with local agents and distributors to support them in their registration process
  • Initiate and review regulatory documents (e.g.Technical file)
  • Ensure compliance with regulations and guidelines as well as company SOP’s
  • Assist in the creation of internal work instructions and SOPs
  • Maintain regulatory records and regulatory database
  • Requirements

  • Experience in Medical devices or Pharma company (1 year)
  • Experience in Medical devices or Pharma worldwide registration
  • Knowledge of EU medical device regulations advantageous
  • Knowledge of Quality Management Systems and GMP advantageous
  • Clincial Database experience
  • SPSS - Stats experience
  • Bachelors Degree
  • Entrepreneurial attitude
  • Benefits

    This is a company filled with talented individuals. They are a small team that get on extremely well creating a friendly and welcoming company culture.

    This role along with career development offers a competitive salary, high bonus and leading benefits. Roles of this nature rarely stay vacant for long, please apply today to avoid disappointment.

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