Clinical Research Scientist (MDR)
The Clinical Research Scientist (MDR) will be responsible for the development of post-market clinical research strategies of orthopedic devices to support global regulatory and post-market surveillance requirements.
· A Bachelor’s degree in Biological Science or related discipline, with a minimum of 4 years’ experience in the medical device industry or healthcare field is required
· Advanced technical writing skills is required, with demonstrated experience in writing PMCF plans / reports strongly preferred.
· Strong project management skills required, with demonstrated track record of success managing multiple projects simultaneously with minimal supervision.
· Ability to communicate effectively and work with teams is required.
· Previous experience developing strategies to generate clinical evidence is strongly preferred.
· Work closely with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to develop post market clinical evidence generation strategies that consider evidence needs for EU Medical Device Regulations (EU MDR). Facilitate clinical evidence reviews with cross functional team to align on clinical evidence strategies, document / track decisions and risks, and write PMCF Plans.
· Develop and write high quality Post-market Clinical Follow-up (PMCF) plans and reports with minimal supervision. Support development and drafting of clinical study protocols, registry plans, epidemiology studies, informed consents, investigator brochures, and other study materials where needed.
· Review summaries of clinical evidence and PMCF strategies in other areas of the Technical Documentation for accuracy and completeness. This includes the Clinical Evaluation Plan, Clinical Evaluation Report (CEP), Post Market Surveillance Plan and Periodic Safety Update Report (PSUR).
· Maintain strong understanding of evolving post-market evidence requirements under EU Medical Device Regulation.
· Where required, foster relationships with surgeons, hospitals, and research teams to gain input into study design, evaluate study feasibility, and identify sites for study execution or data collection. Develop strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders.
· Partner with the Contracts and Payments team to ensure timely execution of all study agreements and corresponding payments for achieved milestones and deliverables.
· Support clinical scientific discussions with internal stakeholders within Clinical, Medical, Regulatory, R&D and Marketing to drive support of the clinical and regulatory strategy, communicate evidence needs.
· Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and Clinical Study Reports (CSR), epidemiology study results and clinical literature.
· Develop a strong understanding of the orthopedic device product portfolio and business needs for clinical evidence to meet regulatory requirements.
COEUS Consulting Group is an equal opportunity employer and will consider all qualified applicants without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity, protected veteran status (if applicable) or any other characteristic protected by law.