MAPSS Compliance Specialist

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System which makes everything possible.

The Marketing Advertising Promotions and Scientific and Sales Material Compliance Specialist “MAPSS Compliance Specialist” will be responsible for ensuring that all product marketing, advertising, promotional, scientific, and sales materials comply with all applicable marketing, advertising and promotional laws, regulations, and standards applicable for EMEA countries. 

The ideal candidate has a strong understanding of quality/regulatory requirements, excellent communication skills, and experience in the medical device industry.

This position is part of the Product Lifecycle Quality MAPSS department and will be located in Solna, Sweden. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

• Review and approve EMEA marketing and advertising materials, including brochures, websites, social media posts, and other promotional content, to ensure compliance with relevant regulatory requirements (e.g., IVDR, ANSM, EU MDR, FDA, FTC).
• Ensure that claims made in advertising and promotional materials are substantiated and that all information is accurate, balanced, and not misleading.
• Provide guidance and support to the marketing team on quality/regulatory requirements and best practices for marketing and advertising of IVD’s.
• Assist in the creation and maintenance of standard operating procedures (SOPs) related to marketing and advertising compliance.
• Prepare, review, submit, and manage documents intended for regulatory submissions to competent authorities for marketing authorizations.

The essential requirements of the job include:

• Bachelor’s degree in biology, Science, or Medical or a related field with 2+ years of related work experience
• 2+ years of experience in regulatory compliance, marketing, or legal roles within the medical device or pharmaceutical industry.
• In-depth knowledge of regulations and guidelines governing medical device marketing and advertising, including FDA, FTC, and international regulations (i.e IVDR, ANSM).
• Excellent written and verbal communication skills, with the ability to clearly convey regulatory requirements and recommendations.

It would be a plus if you also possess previous experience in:

• Strong analytical skills and attention to detail, with the ability to interpret and apply complex regulatory requirements.
• Proven ability to work collaboratively in a cross-functional team environment.
• Familiarity with digital marketing and social media regulations is a plus.

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.