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.
