Specialist 3 - Regulatory Affairs

• 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
• Review/approve Custom Device Requests
• Review/approve Engineering Change Requests/Notices
• 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
• Assist in the development and implementation of SOPs and systems to track and manage product-associated events
• Assist 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
• Ability to handle multiple tasks and be detail oriented
• Ability 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)