Senior Regulatory Affairs Specialist (Onsite/Remote)

Represents the Regulatory Affairs department in assigned project teams and provides regulatory input in accordance with established timelines to meet corporate objectives. Develops and executes sound regulatory strategies to support business goals. Oversees and ensures compliance with state, federal, and international medical device regulations and overall regulatory departmental objectives for new and existing products.

Requirements

• Bachelor's degree in a scientific, engineering, or technical discipline is required.
• Minimum 4 years of directly relevant Regulatory Affairs experience within the medical device or other regulated industry.
• An advanced degree may supplement some professional experience.
• Experience with Class III medical devices is preferred.

Benefits

• Medical, dental, and vision insurance provided at no cost for employee-only coverage
• 401(k) matching plan
• Paid Time Off - starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• Life & AD&D and long term disability insurance
• Education assistance
• Voluntary commuter benefits and pet insurance