Sr Manager, Regulatory Affairs (Medical Devices)

Location: US (Remote)

Company

hirify.global develops orthopedic implants, surgical instruments, and technologies designed to improve surgical outcomes and mobility.

What you will do

• Lead and oversee the Lifecycle (postmarket) Regulatory Affairs team, including hiring, training, development, and work direction.
• Develop and execute global regulatory strategies and timelines for changes to commercialized products.
• Assess regulatory impact, requirements, submission deliverables, and milestone execution for change projects.
• Communicate with regulatory agencies and health authorities regarding registrations, submissions, and regulatory strategies.
• Oversee regulatory review and approval of post-launch advertising and promotion, as well as compliance with Conditions of Approval.
• Support regulatory audits and inspections and help shape the regulatory environment through collaboration with trade associations and regulators.

Requirements

• Bachelor’s degree from an accredited institution, preferably in physical or life sciences; a master’s degree is preferred.
• At least 10 years of experience in regulatory affairs or a related field within the medical device industry.
• Experience with US, EU, and/or international submissions and registrations.
• Working knowledge of US, EU, and international medical device regulations and standards.
• Experience leading technical and strategic discussions with health authorities and influencing cross-functional stakeholders.
• Prior team leadership experience and proficiency with Microsoft Office.

Nice to have

• Orthopedic device industry experience.
• Master’s degree.
• Regulatory Affairs Certification (RAC).

Culture & Benefits

• Remote work arrangement for the US-based role.
• Work focused on innovation in orthopedic implants, surgical instruments, and mobility technologies.

Hiring process

• Initial interview.
• Hiring manager and team interviews.
• Final selection followed by an offer.