Senior Regulatory Affairs Specialist – Recall and Post-Market Compliance

Job Description:

• Represent the Regulatory Affairs function on assigned cross-functional project teams
• Interpret and apply regulations by creating regulatory strategies for domestic and international markets
• Develop and execute regulatory plans for complex projects, including new products and maintenance of existing marketing authorizations
• Prepare hardcopy and electronic information packages for regulatory agency submissions
• Provide recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance
• Review validation, clinical, and stability protocols and reports for regulatory submission soundness
• Assess manufacturing processes and labeling through change control for regulatory reporting impact and compliance
• Define, monitor, and receive submission deliverables
• Write and edit submission documents using regulatory templates or create new templates
• Assemble paper and electronic copies for submission
• Monitor new and revised regulatory requirements and disseminate information
• Interact with regulatory agencies and third-party accrediting bodies
• Prepare internal procedures for continuous process improvement
• Provide regulatory guidance and training to external departments and partners
• Support adverse event reporting, field actions, recalls, post-market surveillance, and regulatory assessments for on-market IVD products

Requirements:

• Minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience
• 5+ years of experience in Regulatory Affairs preferred
• Experience with an in vitro diagnostics device company preferred; pharmaceutical, biologics, or medical device company experience accepted as an alternative
• Strong understanding of FDA regulations required
• Knowledge of EU, Canada, Australia, Japan, and China regulatory requirements preferred
• Ability to work independently with new, complex technologies and produce professional work products
• Strong written and verbal communication skills
• Team leadership skills preferred
• Familiarity with office automation programs and corporate database tools
• Strong work ethic and ability to deliver assignments on time
• Must be eligible to work without visa sponsorship

Benefits:

• Variable cash program (bonus or commission)
• Equity for eligible roles
• Access to genomics sequencing
• Family planning benefits
• Health, dental, and vision benefits
• Retirement benefits
• Paid time off
• Employee Resource Groups offering career development experiences, cultural awareness, and social responsibility opportunities