Sr Regulatory Affairs Specialist (MedTech)

Location: Audubon, Pennsylvania, United States

Company

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

What you will do

• Determine regulatory strategies for new products and document activities required for compliance.
• Prepare and maintain pre-market submissions, filings, license renewals, and annual registrations.
• Evaluate regulatory requirements and the impact of proposed product and process changes.
• Collaborate with cross-functional departments on plans, procedures, product designs, and regulatory decisions.
• Provide regulatory documentation and certificates to support product imports.
• Monitor regulatory procedures and developments and improve submission tracking and control systems.

Requirements

• Minimum of 5 years of related experience with a bachelor’s degree.
• Understanding of regulatory requirements throughout the product lifecycle.
• Solid knowledge of regulatory terminology, pre-market submission types, and related requirements.
• Ability to evaluate the regulatory impact of proposed product and process changes.
• Strong multitasking, project planning, deadline management, and problem-solving skills.
• Ability to work under pressure with a results-driven and responsible approach.

Culture & Benefits

• Work is guided by innovation, customer focus, teamwork, and results-driven execution.
• Focus on developing advanced technologies that improve patient care and quality of life.
• Commitment to ethical business practices, regulatory compliance, and social responsibility.
• Inclusive and respectful workplace with equal employment opportunity.
• Reasonable accommodations are available for individuals with disabilities.