Next Science is currently looking to grow our team with a Regulatory Affairs Manager who will craft and support the regulatory pathways for novel Medical Device products for a large portfolio of products. This position will support US Class II and EU Class IIa, IIb, and III medical devices, including combination products, and will oversee all filings to medical device regulatory agencies.
Develop and present regulatory strategies for novel devices, including combination products.
Represent Next Science in open dialogues with notified bodies and regulators.
Prepare US, EU, and Health Canada Submissions.
Manage change for conversion to EU MDR.
Responsible for International product registration in various countries.
Review labeling and product changes for regulatory compliance.
At least 5 years experience in 510(k)/ DeNovo Regulatory submissions, EU technical file compilation, and Regulatory compliance required. Medical Device experience required, combination product experience preferred. Must be able to work independently and provide internal and external guidance based on previous experience. Bachelor’s degree in a relevant discipline is required.
Internal Number: 30001
About Next Science
Next Science is a leader in innovative, proprietary technologies to address one of the leading causes of antimicrobial resistance, bacterial biofilms. Based on innovative material science and composition-of-matter patents, Xbio™Technology has limitless potential to have a far-reaching and positive impact across all human and animal health care and support the global drive to reduce the threat of antimicrobial resistance caused by biofilms.