Cepheid Regulatory Associate in Solna, Sweden

Danaher Company Description

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for abetter wayand help make life better for us all! For more details, visit us atwww.cepheid.comor follow us on Twitter (@CepheidNews).

Description

Do you want to work for a company that changes people’s lives? Cepheid AB is currently looking for a Regulatory Associate. This role will work mainly administratively for the Regulatory Affairs department. Cepheid is a regulated business and , this role plays a very important part in the work to ensure that our regulatory documentation and business are up to standard, and you would be a highly appreciated member of our team.

Your main responsibilities will be:

• Administrative scheduling of RA activities, submissions, commitments etc.

• Update of regulatory product files

• Assemble files for submissions • Handle request for documents

• Arrange with legalization of documents

• Administrative contact with Medical Products Agency • Document administration and archiving

• Document support during audits

Qualification

In order to be successful in this role we think that you need a University education in a related field such as biochemistry or molecular biology, or enough work experience in a similar field/role to compensate for that.

We are a part of a global company so it is important to be fluent, both in writing and speaking in English and Swedish.

You need to be a very well structured person in order to work in this role. You need to be the person who has everything in order and knows where things are. You should be accurate and have a sense of details, as well as flexible.

If this sounds like something you’d be interested in. Please apply as soon as possible as the position might be filled before last application date.

If you have any questions regarding the role, please contact Lena Kirsel – Regulatory Affairs Manager – at Lena.Kirsel@cepheid.se

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

Organization: Cepheid

Job Function: Quality and Regulatory Affairs

Primary Location: EMEA-Western Europe-Sweden-Stockholm-Solna

Schedule: Full-time

Req ID: CEP000960

Cepheid is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.