Regulatory Affairs Specialist in Medical Device

Do you want to work in a big medical devices company? Do you have more than 4 years experience in Regulatory Affairs ? You should then read the following lines!

Our client, based in Solothurn, is looking for a Regulatory Affairs Specialist for a mission until the end of 2022.

OVERALL RESPONSIBILITIES

Support the internal Regulatory Affairs group in creation and maintenance of technical documentation supporting compliance to

• European Council Directive 92/42/EEC or Regulation 2017/745, as applicable,

• US FDA 510(k) submissions or Note to files, as applicable,

• As well as country registrations on a world-wide basis, as appropriate.

POSITION DUTIES & RESPONSIBILITIES

• Ensuring that the company's products comply with the regulations set up by government agencies

• Advising engineering and other support functions, as well as manufacturing on regulatory requirements

• Assisting with reviewing of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining any required regulatory activities

• Creating, reviewing and maintaining regulatory related technical documentation

• Supporting maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals

• Capturing and verifying regulatory product characteristics to support logistic and supply chain efforts on a global scale

• Working with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assisting in review of international product technical documents, marketing and labeling materials

• Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations

• Providing progress of work-plans and the status of key project deliverables

WHO YOU ARE:

You have few years experience as a regulatory affairs associate

Experienced in the medical device industry

You speak fluent english, German and/or French an advantage