Senior Regulatory Affairs Specialist (IVD experience required)

The Senior Regulatory Affairs Specialist is responsible for creating and executing the regulatory plans for Biocartis’ diagnostic development programs and securing timely marketing authorizations according to agreed-upon plans.  The Senior Regulatory Affairs Specialist will support communications with regulatory authorities, including submissions, product registrations, and execution of any post market commitments as required. 

Accountabilities

• Create regulatory strategy to efficiently obtain regulatory approvals for Biocartis’ products including those for Companion/Complementary Diagnostic use Communications with local and international authorized representatives and regulatory authorities Work closely with R&D teams to implement development efforts compliant to the IVDR, US 21 CFR 820, and global regulatory requirements Work with Clinical Affairs to create clinical validation strategies to meet regulatory requirements Review and edit technical documentation including: Product Validation Protocols and Reports Software documentation Risk Management documentation Compile and Write regulatory submissions including but not limited to EU Technical Documentation, FDA Pre-submission documents, IDE applications, pre-market notifications/applications and post-market reporting Conduct regulatory intelligence/research to assist in formulation of regulatory plans Review product complaints for compliance to vigilance procedures Participate in periodic post market product data analysis processes; ensure post-market reporting requirements are met Monitor regulatory requirements in various markets to ensure preparedness for upcoming changes Participate in regulatory audits/internal audits and inspections as appropriate

Profile requirements

• Bachelor’s degree with preference for scientific, engineering or legal studies or equivalent through experience or training;
• Min. 5 years of experience in Regulatory Affairs;
• IVD/medical device experience preferred, especially PCR or software experience;
• Must have highly effective organizational and planning skills to apply daily in a multidisciplinary environment;
• Must be able to work effectively in a strongly matrixed team-oriented structure using excellent communication, interpersonal and relationship management skills to successfully interact with Clinical, Research and Development, Manufacturing, Quality, Marketing, Operations and corporate partner counterparts;
• Regulatory Affairs Certification is a plus;
• Proven experience with:
  • In-vitro diagnostics validation requirements and regulations; global regulatory understanding is preferred;
  • Ability to read, analyze and interpret complex data and review technical documents;
  • Excellent written and oral communication skills;
  • Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency;
• Legislation and regulation:
  • US CFR Title 21 (applicable sections)
  • IVDD & pending IVDR
  • GDPR
  • Various Market regulations, as assigned
• PC skills:
  • Applied knowledge of MS office (Outlook, Excel, Word, PowerPoint)
  • Applied knowledge of an ERP system, preferably Microsoft Dynamics AX
• Languages: fluent English, written and spoken

Our offering

We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package which includes a Flexible Income Plan.