Coloplast
The Regulatory Affairs Specialist ensures medical devices are developed, registered, and commercialized in compliance with US and Canadian regulatory requirements throughout the product lifecycle. The role involves collaborating with global teams to develop regulatory strategies, prepare FDA and Health Canada submissions, and maintain product compliance. The specialist also conducts regulatory impact assessments, reviews product labeling, and monitors emerging regulatory intelligence.
Coloplast is a global medical device company that develops and manufactures products and services for people with intimate healthcare needs. Their offerings span ostomy care, continence care, interventional urology, bowel care, wound and tissue repair, and voice and respiratory care. They serve over 2 million people annually across more than 100 countries, and also provide support services for both patients and healthcare professionals.
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
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