Over 20 years of experience in medical device industry with focus on Regulatory Affairs
Expert in MDR, Regulatory Affairs, Submission Management, 510K as well as Technical Documentation
Placed several times via K-Recruiting and received excellent customer feedback
Reliable, proactive and team-oriented personality with agile hands-on mentality
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Our content and services may vary by location.
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- PhD in Chemistry
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Regulatory Affairs, Approbation and Submission, MDR, Technical Documentation, 510 (k), FDA; PMA, Combination Products, IVDR, Certification and Re-Auditing (TÜV), ISO 13485, ISO 14971, IEC 60601, IEC 62366, Active/non active Medical Devices
Key-Facts
Extract from Previous Activities
Medical Device Company, Germany (via K-Recruiting)
Regulatory Affairs Consultant
Identify, interpret, and disseminate new regulatory trends, expectations and guidance documents
Responsible for assessment of device changes for regulatory implications
Develop approaches for regulatory activities
Interim Lead in identifying regulatory risk areas and developing alternative courses of action
Assess impact of new regulations and works with the Organization to implement appropriate changes
Review and approve Regulatory Affairs documents, procedures, SOPs, regulations and filings
Creation and submissions of US FDA pre-submissions, 510(k)s and PMAs for assigned projects
Design Dossier remediation and resubmission for CE marking and certification acc. MDD 93/42/EC, incl. Risk Management ISO 14971
Gamma Sterilization Validation (ISO 11137-1 &-2, ISO11737-1 &-2)
DHF & Technical File remediation incl. ETO-Sterilization
Medical Device Company, Germany (via K-Recruiting)
Interim Regulatory Affairs Lead
Preparing, submitting and managing FDA submissions (PMA’s/IDE’s/PMA Supplements/ Pre-submissions)
Regulatory lead for Companion Diagnostics (CDx) development projects, from feasibility to approval
Create technical documentation and International Registration Dossiers including Health Canada and PMDA
Provide Life Cycle Management support to ensure all product changes meet regulatory requirements
Liaise with internal and external project stakeholders on global regulatory strategies, requirements, & submissions
Medical Devices Company, Germany
Regulatory Affairs Expert
Intensive project support in product development
Ensure regulatory compliance during design, development, production, and market monitoring
Application of standards (IEC 60601-1, ISO 80601-2-12, IEC 62304) to products and processes
Global medical device registration, with a focus on EU and US markets, including coordination with notified bodies
Medical Device Company, Germany (via K-Recruiting)
Regulatory Affairs & Clinical Studies Expert
Define regulatory requirements for innovative healthcare solutions combining hardware and software components
Streamline the development process (intended use, performance analysis, usability tests, clinical evaluation) with a cross-functional team
Engage with external partners to inform clinical study design
Guide and actively participate in the development of technical documentations
Medical Device Company, Germany
DHF Remediation Consultant
DHF remediation for FDA 510(k) notification for lumbar/ cervical cage implants
Update technical file and create DHF to fulfill US requirements