The Integer Group is seeking a Senior Regulatory Affairs Specialist to oversee regulatory activities for medical devices, ensuring compliance with FDA, EU, and ISO standards. The ideal candidate will have over seven years of experience in regulatory submissions and approvals, along with strong communication and technical writing skills
Job Summary
The primary purpose of this job is to strategically plan, execute, and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets.
Candidates must have a minimum of 7+ years of US and International medical device regulatory submission and approval experience including specific knowledge of FDA, MDD, PMDA, TGA, and TPD requirements.
The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with company matching contributions.
Matching Summary
Match Score: 85
The Integer Group is seeking a Senior Regulatory Affairs Specialist to oversee regulatory activities for medical devices, ensuring compliance with FDA, EU, and ISO standards. The ideal candidate will have over seven years of experience in regulatory submissions and approvals, along with strong communication and technical writing skills.
Salary
Base: $113,025 - $165,770; Bonus/Equity: Cash-based incentive program available; Benefits: Comprehensive package including medical, dental, vision, 401(k) match, and paid time off
Skills & Requirements
Must-have
7+ years medical device regulatory experience
FDA, MDD, PMDA, TGA, TPD submission knowledge
ISO 9000 and FDA Quality System regulations
Strategic planning for product development teams
Post-market incident report evaluation skills
Nice-to-have
Strong technical writing and communication skills
Experience with supplier and customer relations
Ability to work through difficult issues collaboratively
Proficiency in spreadsheet and word-processing software