Senior Clinical Evaluation & Regulatory Affairs Specialist
Proclinical is recruiting for a Clinical Evaluation and Regulatory Affairs Specialist for a leading analytical lab and software company located remotely. As the Clinical Evaluation and Regulatory Affairs Specialist, you will be responsible for the long-term strategy for developing and maintaining sufficient clinical evidence to support the clinical evaluation over the life-cycle of the in vitro diagnostic medical devices.
- Participate as a core team member on new product development teams to support risk analysis through post market clinical literature reviews and to provide guidance on clinical performance study design and regulatory planning
- Liaison with bio-statistician and external CRO to ensure adequate study design
- Provide input to the clinical requirements section of regulatory strategies for new and modified products
- Support regulatory affairs for pre-IDE submissions as assigned
- Prepare Clinical Performance Evaluation Reports per 2017/746
- Prepare clinical performance sections for international regulatory submissions as assigned
- Conduct comprehensive post market clinical literature reviews per MEDDEV 2.7.1
- Manage clinical performance studies or external CRO lead studies in accordance with ISO 20916
- Support Health Hazard Assessments as needed
- Cooperate with Medical Advisor on Health Hazard Assessments, Risk Analysis and Clinical Literature Reviews
- Provide guidance to regulatory specialists as needed to support clinical strategy requirements
- Mentor Regulatory Specialists on Clinical Evidence
- Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US and OUS guidelines)
Skills and Requirements:
- Bachelor's degree required preferably in science or engineering
- Advanced degree and/or RAC certification is an advantage
- Must have a minimum of 4 years of medical writing experience
- Minimum of 2-4 years of experience in clinical evaluation report writing in a medical device industry is preferred
- Previous clinical evidence and regulatory affairs experience in the application of therapeutic and In Vitro Diagnostic medical device knowledge to development of clinical evaluation strategy, systematic literature reviews, preparation of clinical evaluation reports and regulatory strategies in a Medical Device environment
- Experience in conducting literature searches, reviews and appraisal of the scientific data
- Demonstrated effective scientific writing skills
- Self-starting demonstrating initiative
- Excellent critical and analytical thinking skills
- Must have high level of attention to detail, accuracy and organization.
- Must be able to work effectively on cross-functional teams to manage multiple projects across disciplines and ensure adherence to timelines
- Strong communication, presentation and interpersonal skills
- Working knowledge of statistics to apply and understand appropriate study design and systematic literature review is an advantage
- In-depth knowledge of In Vitro Diagnostic regulatory process (CE Marking, IDE, 510(k), post-market/post approval), GCP procedures, and legal compliance for medical device industry
- Knowledge of LC/MS/MS and Software regulations is a plus
If you are having difficulty in applying or if you have any questions, please contact Nick Walker at (+1) 646-367-2908 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.