Remote Regulatory Clinical Scientist

Actalent Remote
remote regulatory scientist medical evaluation management regulatory scientist devices research engineering safety writers
November 19, 2022
Actalent
Pleasanton, CA
FULL_TIME
*Hiring Regulatory Scientist-Medical Device * The function of a Clinical Evaluation Scientist is to combine understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, and EU MDR 2017/745. The Clinical Evaluation Scientist will interact cross-functionally with various personnel to identify and obtain relevant documentation and data on safety, performance, adverse events and risk/benefit profile of a device or devices. The Clinical Evaluation Project Manager will write and edit, as needed, Clinical Evaluation Plans and Clinical Evaluation Reports, Post-Market Surveillance Plans, Post-Market Clinical Follow-Up Plans and Reports, and Summary of Safety and Clinical Performance, or interact with vendor medical writers to create CER deliverables. Moreover, the Clinical Evaluation Scientist may be requested to contribute to other activities such as risk assessment and management, and review of informational documents like the Instructions for Use. The Clinical Evaluation Scientist also may sit in on core team product development and respond to additional information requests from regulatory agencies. Main Responsibilities:  Compliance with applicable corporate and divisional policies and procedures.  Manage content and timelines for deliverables drafted by vendor medical writers.  Write and edit, as needed, CER deliverables. Critically analyze clinical data and draw conclusions on risk-benefit and safety & performance  Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical Engineering, Library Services, Clinical Affairs, Risk Management, Project Management, as well as external vendors such as Medical Writers and Medical Reviewers). *Requirements:*  Training and degree in science, engineering, or medical fields. Scientific/research background (i.e., has understanding of research design, methodology, and statistics)  A college degree (Bachelor’s) is required; post graduate degree (Masters or Doctorate) is preferred.  Experience writing CERs and related documents in accordance with MEDDEV 2.7/1 Rev 4 is preferred.  Understanding of regulations, standards and guidelines related to medical devices, risk management, clinical studies, and quality systems, including: MDD 93/42/EEC; MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485.  Effective written, verbal and presentation skills in the area of technical/clinical applications.  Strong command of medical and surgical terminology.  Project management and/or management of people experience is preferred.  3 years of experience in clinical research, clinical engineering, risk management, post-market surveillance, or regulatory affairs in medical device or pharmaceuticals industry  Experience in cardiac devices preferred.  Demonstrated ability to identify and adapt to shifting priorities and competing demands. Highly-developed interpersonal skills, and strong attention to detail.  Able to travel as needed. About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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