Senior Regulatory Affairs Specialist USA (FDA)

We are looking for a Senior Specialist with strong knowledge and experience from working with the FDA.

The purpose of this position is to obtain and maintain marketing authorizations for the company’s products in USA and ensuring compliance with laws and regulations set by the Regulatory Agency for Healthcare Products in USA (FDA).

The role will be responsible for the regulatory strategy and guidance to organization on regulatory affairs matters. This includes regulatory affairs matters throughout the life cycle of a medical device from product development to placing product on market, aswell as ongoing commercial supply and product maintenance in USA.

This role will perform regulatory affairs review and approval of product labelling and marketing material for US market. The role will surveille new and changed regulatory requirements and guidance published by FDA and be responsible for maintaining technical files (510k).

The Company is looking for a Senior Specialist that actively will contribute to continuous improvements of regulatory and quality processes. A team-player, a doer and a skilled collaborator with a positive mindset and is continuously motivated and curious. You have drive and motivation and you are meticulous. In this role, the details are important.

At least 5 years working experience in regulatory affairs is expected and at least 2 years working with RA matters with USA/FDA within medical device business is required.

The position is based in Stockholm, but the Company is operating on the global market.
English is the business language. 

If this is a position that appeals to you and you believe you have the required experience, skills, knowledge and commitment, please apply for this position here: 

If you would like to learn more about this position, please contact Ulrika Nyberg at +46 708 80 04 07 or uny@bondi.se