Job Description
The role involves authoring Clinical Evaluation Documents for EU MDR. The candidate must have experience in authoring CER, CEP, PMCF Plans & Reports. Responsibilities may include the following and other duties may be assigned:
- Review and summarize scientific literature.
- Report instances of complaints/adverse events from literature to GCH.
- Create responses for audit/submission queries.
- Maintain a database of peer-reviewed literature.
- Appraise, analyze, summarize, and discuss clinical evidence from all available sources.
- Conduct comprehensive literature searches and perform a critical evaluation of clinical evidence.
- Develop state of the art on product family for its intended purpose.
- Create & maintain plans and reports for regulatory authorities.
- Review/approve other documentation for device development.
- Possess knowledge of regulatory agencies' guidelines on clinical evaluation requirements.
Must Have - Deep knowledge of EU MDR and Medical Writing from CER, CEP, PMCF Plan & Report.
- Ability to tackle difficult problems and issues, requiring an understanding of multiple issues, job areas, or specialties.
- Capability to make improvements to processes, systems, or products to enhance job area performance.
- Provide in-depth analysis and recommendations on process improvements.
Years' Experience Required Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A)) and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years relevant experience. Preferably, 5 years of experience.
Work Location Can be located in Lafayette, Colorado, or any site in MN, or remote. No requirement to be on site full time or part time.
Specialist Career Stream Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
Differentiating Factors - Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects/processes.
- Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
- Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
- Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas, and issues to achieve objectives and influence decision-making.
- Leadership and Talent Management: May provide guidance, coaching, and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
Job Tags
Full time, Part time, Remote work,