Regulatory Affairs Specialist (Medtech)

Location: Audubon, Pennsylvania, United States

Company

hirify.global develops medical technologies and surgical solutions designed to improve outcomes for patients with musculoskeletal disorders.

What you will do

• Assess proposed product, supplier, and process changes for regulatory impact and document related activities.
• Provide regulatory support for line extensions and existing products in accordance with local and regional registration requirements.
• Review product literature and marketing materials, including presentations, advertisements, and social media content, for regulatory compliance.
• Collaborate with cross-functional departments on plans, procedures, and regulatory decisions.
• Monitor and improve regulatory tracking and control systems.
• Review technical publications and industry developments to maintain current regulatory knowledge.

Requirements

• At least two years of related experience with a bachelor's degree, or one year with a master's degree, or equivalent experience.
• Two or more years of experience in the medical device industry.
• Understanding of regulatory requirements throughout the product lifecycle.
• Knowledge of regulatory terminology, pre-market submission types, and applicable requirements.
• Ability to evaluate regulatory impacts, manage multiple priorities, plan projects, and meet deadlines.
• Ability to work under pressure with a strong sense of responsibility and urgency.

Culture & Benefits

• Work within a culture focused on innovation, patient care, customer service, teamwork, and decisive execution.
• Maintain compliance with applicable United States and international laws, regulations, and company policies.
• Follow the company Code of Conduct, AdvaMed Code, MedTech Code, and related compliance standards.
• Reasonable accommodations are available for individuals with disabilities.
• Full-time employment with equal employment opportunity and an inclusive, respectful workplace.