For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
ProPharma are looking for a German-speaking Regulatory Medical Device Contractor in Germany. Must be a skilled contractor to assist us with our medical device projects. The contract duration is 6 months, and the work can be done remotely from home.
The ideal candidate will have a proven track record in regulatory compliance, risk management, biocompatibility, clinical evaluation, MDR documentation, conformity assessment, and international approvals.
The contractor should have experience in accompanying development projects to ensure compliance with regulatory requirements, keeping risk management files, and supervising usability studies. They should also have expertise in evaluating RoHS/REACH conformity and biocompatibility, preparing clinical evaluations, maintaining technical documentation according to MDR requirements, participating in the conformity assessment procedure, and coordinating all departments involved.
The contractor should also be skilled in communicating effectively with regulatory authorities and the Notified Body and have experience in supervising international approvals.
If you are a Regulatory Medical Device Contractor based in Germany and meet these requirements, we want to hear from you! Please send your CV and relevant experience to Charlie.harris@propharmagroup.com
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ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving the pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio... Read More
