• In this role, you will support the development and implementation of long-range regulatory strategies that impact the introduction of new products and the compliance of existing ones
• Your leadership will guide regulatory staff, ensuring all products meet U.S. and international standards
• You will be a key player in compliance activities and bear significant responsibility in product development and modifications
• Maintain current knowledge of applicable laws and regulations
• Interpret regulatory requirements for products and ensure compliance
• Participate as a regulatory representative on project teams
• Lead submission activities for device clearances/approvals
• Review change orders and assess regulatory impact
• Oversee labeling, training, and promotional material compliance
• Represent the organization in working groups related to regulatory objectives
• Support due diligence and post-acquisition assessments
• Develop and implement regulatory education and training

Assist in policy and procedure development within the department

• Bachelor’s Degree with 7+ years in regulatory affairs or relevant field
• Medical device experience is required
• Experience with 510(k) or PMA submissions for FDA
• Knowledge of U.S. and EU regulations for medical devices
• Excellent communication and presentation skills
• Ability to manage multiple projects with attention to detail

Proficiency in MS Word, Excel, and PowerPoint

• Competitive salary and flexible benefits package
• Health, Dental, and Vision insurance
• 401(k) plan with employer match
• Paid time off and holidays
• Tuition assistance and reimbursement
• Employee Stock Purchase Plan
• Short-term disability and life insurance

Employee Assistance Program