4-6 years of regulatory experience in medical devices or relevant industry
Ability to solve problems and advise on regulatory issues
Experience in labeling review and approval processes
Familiarity with clinical research and regulatory requirements (GxPs)
Responsibilities
Compile and submit regulatory documentation to authorities
Monitor and respond to regulatory reports for Orthopedic devices
Interface with Product Development for necessary regulatory information
Review and approve Custom Device and Engineering Change Requests
Maintain and update regulatory database for compliance reporting
Benefits
Training opportunities on current and new regulatory requirements
Participation in professional associations and industry groups
Health, Safety, and Environmental practice guidelines
Support for compliance program activities
Opportunities for career advancement through contributions to product lifecycle planning
Full Job Description
Job Description:
Prepare regulatory documentation to support the market distribution of new and modified medical devices (510(k)/NTF) in US, Canada, and EU. Support global registrations in rest of world. Review device Labeling, including all graphic material.
Prepare export certificates, medical device listings, annual establishment registrations for submission to the U.S. Food and Drug Administration (FDA). Assist group in maintaining regulatory databases for all products. Provide support to Regulatory Manager for special projects as needed.
Responsibilities:
Compile, prepare, review and submit regulatory submission to regulatory authorities
Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities for division Orthopedic devices
Interface with Product Development to obtain necessary information for regulatory submissions
Prepare export certificates, medical device listings, and annual establishment registrations
Respond to requests for information on import detentions
Maintain regulatory database - ongoing update of database with regulatory information
ssist in the development and implementation of SOPs and systems to track and manage product-associated events
ssist in the development of regulatory strategy and update strategy based upon regulatory changes
Provide regulatory input to product lifecycle planning
Evaluate regulatory impact on proposed products
Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval
Determine and communicate submission and approval requirements
Begin to participate in risk-benefit analysis for regulatory compliance
Submit and review change controls to determine the level of change and consequent
Requirements:
BS Degree in Science or Engineering required
Four to six years related regulatory experience in medical devices or relevant medical device industry experience
Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
Provide training for staff on current and new regulatory requirements
Communicate regulatory agency/industry positions within the regulatory department
Problem-solve with and advise internal stakeholders on regulatory issues
Identify standards for the organization's products
Participate in professional associations, industry/trade groups (local/regional/international) and appropriate standards organizations
Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Review/approve labeling: device labels, brochures, technique guides, bulletins, updates, etc.
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed
Skills:
Excellent written and oral communication skills
Excellent organizational skills preferred
bility to handle multiple tasks and be detail oriented
bility to apply risk-benefit analysis techniques
General knowledge of Submission types and requirements
Knowledge of clinical research, clinical operations, and nonclinical, quality, and regulatory requirements and GxPs (GCPs, GLPs, GMPs)
