Research Scientist to be responsible for the development of
post-market clinical research strategies of orthopedic devices to
support global regulatory and post-market requirements.
Responsibilities to include the following
closely with cross-functional teams Clinical, Medical, Regulatory,
R and D, Marketing to develop post market clinical evidence
generation strategies that consider evidence needs for EU Medical
Device Regulations. Facilitate clinical evidence reviews
with cross functional team to align on clinical evidence strategies,
document , track decisions and risks, and write PMCF Plans.
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.
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
strong understanding of evolving post-market evidence requirements
under EU Medical Device Regulation.
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.
with the Contracts and Payments team to ensure timely execution of
all study agreements and corresponding payments for achieved
milestones and deliverables.
clinical scientific discussions with internal stakeholders within
Clinical, Medical, Regulatory, R and D and Marketing to drive
support of the clinical and regulatory strategy, communicate
to appropriate interpretation and dissemination of all evidence
generated, including abstracts, manuscripts, and Clinical Study
Reports CSR, epidemiology study results and clinical literature.
a strong understanding of the orthopedic device product portfolio
and business needs for clinical evidence to meet regulatory