Manager Regulatory Affairs System to Thermo Fisher Scientific

Thermo Fisher Scientific is recruiting a Manager to the Regulatory Affairs System group. This is an opportunity to combine specialist skills within regulatory affairs and evolving your leadership skills by managing a team that today comprises of three colleagues.

The role

This is a new position that has been created due to an increased need for expertise on regulatory system-related issues. In this role, you are responsible for activities of the Regulatory Affairs System team that support the compliance, registration, maintenance, and promotion of existing and new products. You are responsible for the resource allocation of the team’s activity in different projects and you will also represent your team internally in all company activities.

As a Regulatory Affairs Manager, you will be a part of making the world healthier, cleaner, and safer by helping patients around the world. You will join our Quality and Regulatory team in Uppsala, which is the headquarters for our global business within Immunodiagnostics.

Key Responsibilities

As part of our Regulatory Affairs System team, you will also:

• Lead and actively participate in product registration projects for defined global markets, incl. communication with internal and external partners.
• Compile and submit the required documentation to obtain registration licenses.
• Representing regulatory affairs in product development and product care projects, e.g. compiling regulatory assessments.
• Issue, review and or approve product documentation.

Your Profile

• A university degree or equivalent in a relevant technical subject (e.g. engineering, electronics or mechanics).
• Previous experience within the medical device or diagnostic industry working with software related regulatory affairs
• A minimum of five years’ experience in regulatory affairs management, such as compiling performance documentation
• for regulatory submissions (510K) with authorities for regulated medical device products.
• Good knowledge and work experience of IEC 62304 as well as ISO 13485
• Good communication skills and to be skilled at work across departments, in a matrix organization.
• Essential ability to speak and write English on a professional level, independent understanding of Swedish.

Application

In this recruitment, Thermo Fisher Scientific is collaborating with Mpya Sci & Tech. Please submit your application as soon as possible and no later than 31th of January. If you have any questions regarding the recruitment process or about this role, you are welcome to contact Johan Östman, 076-628 78 91 or email johan.ostman@mpyascitech.com

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.