Strategist, Regulatory Affairs (Medical Devices)

TL;DR

Strategist, Regulatory Affairs (Medical Devices): Managing global regulatory registration, renewal, tender, customs, and medical device submission documentation with an accent on US FDA, EU MDD/MDR, ISO 13485, and document control. Focus on coordinating submissions, resolving regulatory queries, managing certificates and legalizations, and maintaining accurate records across international projects.

Location: Hybrid position based in Cincinnati, Ohio, United States, with regular office attendance at 4545 Creek Rd, Blue Ash, OH 45242.

Company

hirify.global is a global full-service contract research organization providing clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

• Manage, plan, prepare, and deliver electronic and paper-based documents for global regulatory registrations, renewals, tenders, and customs activities.
• Coordinate medical device applications and provide regulatory information and documentation through inspection and approval.
• Prepare and review authorizations, cover letters, declarations, powers of attorney, certificates, and other submission documents.
• Submit and manage US FDA Certificates to Foreign Government applications.
• Coordinate document legalization, notarization, and apostille activities while maintaining regulatory tracking tools.
• Communicate with internal teams, clients, and project stakeholders to resolve inquiries and ensure timely delivery.

Requirements

• Bachelor’s degree, preferably in life sciences or a regulatory-related field.
• At least 1 year of hands-on medical device regulatory affairs experience, or 3 years of combined regulatory affairs and related experience.
• Basic knowledge of US FDA QSR, ISO 13485, and EU MDD/MDR requirements.
• Good understanding of current Good Documentation Practices in a regulatory environment.
• Proficiency in Microsoft Office, including Word, Excel, and PowerPoint.
• Strong organization, attention to detail, planning, multitasking, written communication, and verbal communication skills.

Nice to have

• Knowledge of global medical device registration processes.
• Life sciences educational background.

Culture & Benefits

• Permanent full-time employment in a collaborative, quality-focused one-team environment.
• Professional development supported by continuous training and structured learning.
• Work-life balance and a diverse, inclusive workplace.
• Opportunity to support the development and commercialization of innovative drugs and medical devices.

Hiring process

• Submit a CV and receive an application acknowledgement.
• Qualified candidates are invited to a phone interview as the first step.