Supports in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals.
Represent regulatory affairs on project/product teams, risk management, and all design review meetings.
Working with department management provides regulatory guidance and guidance on applicable standards to cross-functional groups
Working with department management provides global regulatory strategies and regulatory plans
Working with department management, communicates with US FDA, EU Notified Bodies, EU Competent Authorities and other international regulatory authorities
Coordinates/prepare and maintains FDA PMA and 510(k) Premarket Notifications in accordance with US FDA requirements
Coordinates/prepare and maintains CE files in accordance with current Medical Device Directive requirements, manages Essential Requirement checklists and ensures timely updates for all applicable CE certifications
Coordinates and prepares responses to FDA/NB or other such regulatory agency letters.
Supports Reviews of product labeling changes
Reviews promotional literature and marketing materials
Support CAPA and CAPA closure
Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company
Participates in regulatory audits/inspections as required
Writes SOPs and train key personnel as needed
Perform other duties as assigned
Project management skills
Degree in RA or Regulatory Affairs Certification a plus
Must be able to work under pressure to meet regulatory reporting time frames and company requirements
Must be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolution
Knowledge of U.S. and European/International regulations and standards
Experience interacting with FDA and/or other regulatory agencies
Must work well in team environments
Must demonstrate leadership skills in team setting.
Proven analytical abilities, Able to apply problem-solving skills for problems of moderate to diverse scope
Solid understanding of manufacturing and change control, and an awareness of regulatory trends
Understanding of engineering concepts and scientific terminology
Superior interpersonal skills
Excellent communication skills, both oral and written
Proven ability to prioritize, conduct, and manage time to meet project deadlines
Documented evidence of writing skills
Basic understanding of computer applications
Familiarity with medical terminology a plus
Some travel is required ~10%
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification.