Regulatory Affairs Leader
Roles and Responsibilities:
This position provides regulatory subject matter guidance. Will work with a team of Regulatory Affairs professionals to ensure GEHC establishes best practices in compliance with regulatory requirements. This role will be involved with regulatory activities in the areas of premarket submissions, post-market reporting, regulatory intelligence, regulatory requirements flow-down advertising and promotion review, product labeling compliance, etc.
1. Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets
2. Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc), product claims and country regulatory dependencies to ensure optimized sequencing for submissions,
3. Works with a cross functional team to prepare and submit regulatory submissions to regulatory authorities for the purpose of obtaining authorization for market launch.
4. Assesses changes in existing products to and determines the need for new / revised licenses or registrations.
5. Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.
6. Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
7. Contributes to writing and editing technical documents
8. Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions
9. Understands and applies regulatory requirements and their impacts for submissions
10. Ensures compliance with pre- and post-market product approval requirements
11. Supports regulatory inspections as required.
12. Assesses adverse events and field actions for reportability to regulatory authorities and prepares and submits reportable events and recalls in a timely manner to regulatory authorities, as per country regulations.
Required Skills and Experience:
• Bachelor's Degree or a minimum of 4 years work experience.
• Minimum of 1 year of experience working in a regulated industry
• Ability to communicate effectively in English (both written and oral).
• Ability to work effectively with a global cross-functional team.
• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
Desired Skills and Experience:
• 3 years of experience medical device regulatory affairs.
• Advanced degree in scientific, technology or legal disciplines
• Regulatory Affairs Certification (RAPS)
• Statistics education and or training
• Ability to work independently in fast-paced environment with little supervision.
• Ability to adapt to constant change and influence positive change effectively.
• Team-oriented and responsive to customer needs.
• Attention to Detail and Results-Oriented.
• Ability to understand technical documentation and execute associated pr