- Compose high quality Post-market Clinical Follow-up (PMCF) plans and reports with next to no supervision. Assist in the development and drafting of clinical study protocols, registry plans, epidemiology studies, informed consents, investigator brochures, and other study materials where applicable.
- Work similarly with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to create post market clinical evidence generation strategies that deem evidence needs for EU Medical Device Regulations (EU MDR).
- Able to efficiently facilitate clinical evidence reviews with cross-functional teams to align on clinical evidence strategies, document / track decisions and risks, and write PMCF Plans.
- Aid in clinical scientific discussions with internal partners and cross-functional teams (Clinical, Medical, Regulatory, R&D and Marketing) to drive support of the clinical and regulatory strategy, as well as communicate evidence needs.
- Contribute to suitable interpretation and distribution of all evidence that is generated, including Clinical Study Reports (CSR), abstracts, manuscripts, 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.
- 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 (CEP), Clinical Evaluation Report (CER), Post Market Surveillance Plan and Periodic Safety Update Report (PSUR).
- Ability to foster collaborative relationships with research teams, hospitals, and surgeons to gain insight into evaluating study feasibility, identify sites for study execution or data collection, and the study design. Ability to communicate efficiently with the core team and others to ensure progress of the study for assigned projects, as well as ensuring that issues are identified and communicated to leaders.
- Bachelor's degree in Biological Science or related course of study, with a minimum of 4 years' experience in the medical device industry or healthcare field.
- Strong Project Management skills are required, with verifiable background of success managing multiple projects simultaneously with minimal supervision.
- Previous experience developing strategies to generate clinical evidence is strongly preferred.
Developed technical writing skills are required, with demonstrated experience in writing PMCF plans and reports is strongly preferred.
- 100% remote, Eastern Time Zone preferred
- Health insurance
- 401k match
Casual Dress code