Clinical and Regulatory Affairs Specialist
Behavioral Health Market Context
Apply Nowvia Career In Regulatory Affairs - RAPS
Qualifications
- •A bachelor’s degree in life sciences or a technical field
- •RA certification (RAC) in the U.S. and/or EU
- •At least 3 years of working experience in a regulatory/clinical department of a medical device company
- •Basic knowledge of FDA, EU, and other regulatory agencies rules and regulations, including GCP for medical devices (e.g., ISO 14155, 21 CFR 812, ISO 13485, CMDR, MDSAP)
- •Attention to detail
- •Good computer skills with knowledge of Microsoft Office and QMS Systems
- •Fluent in English with strong verbal and written communication skills
- •detection, evaluation, and management of GI diseases across the esophagus, stomach,
- •focused on motility assessment and advanced imaging
- •6 more items(s)
Responsibilities
- •The successful candidate will be experienced in working within the medical device industry, preferably startups, with knowledge in clinical and regulatory affairs of medical devices
- •They will ensure that regulatory and clinical projects and practices are aligned with business objectives while maintaining compliance with all applicable rules, regulations, and requirements
- •Coordinate the development of clinical study protocols and related clinical study documentation
- •Coordinate the activities for implementing company sponsored clinical studies (e.g., ethic approval, registration in clinicaltrials.gov, finalizing contracts and agreements, etc.)
- •Supervise the execution of company sponsored clinical studies
- •Coordinate the preparation and submission of regulatory applications
- •Provide regulatory guidance to development project teams regarding design, development, and evaluation of the company products
- •Provide regulatory guidance to department teams regarding marketing and sales of the company products
- •Coordinate the development of regulatory strategies and implementation plans for the preparation and submission of new products
- •Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies, as required
- •Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes and company products
- •Serve as the contact point for colleagues within the company in terms of all questions concerning the technical documentation and the approval/clearance of the company products
- •Provide staff training on regulatory affairs issues and good clinical practice
- •Oversee documentation efforts to ensure compliance with domestic and international regulations and standards
- •Review materials such as marketing literature, user manuals, instructions for use, etc
- •to ensure that regulatory requirements are met
- •Manage/Coordinate activities such as regulatory agency inspections, product recalls, reporting adverse events to regulatory authorities, etc
- •Perform other duties as assigned
- •Primarily in an office environment
- •Domestic and international travel up to 20%
- •17 more items(s)
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