Manager Regulatory Affairs (Medical Devices)

Location: Hybrid role at the Eagan, MN ADC site; up to 15% travel required.

Salary: $116,000–$174,000 annually, plus bonus and/or incentive eligibility.

Company

hirify.global Industries develops and supports medical products and operates as a growing worldwide healthcare organization.

What you will do

• Lead regulatory strategies for domestic and international medical device approvals.
• Guide regulatory and licensing decisions based on applicable medical device requirements.
• Oversee regulatory filings, supporting technical evidence, and responses to regulator questions, deficiencies, and non-conformances.
• Develop and implement pre-market and post-market regulatory compliance processes with regulatory, R&D, quality, and medical affairs groups.
• Monitor regulatory and legislative changes and recommend appropriate pathways, solutions, and future actions.
• Manage Regulatory Affairs employees, including hiring, development, performance reviews, work assignment, and policy implementation.

Requirements

• Bachelor’s degree in Regulatory Affairs, Life Sciences, or Engineering.
• At least 4 years of regulatory affairs experience in the medical device industry.
• Strong knowledge of pre-market approvals or clearances and post-market medical device requirements.
• Ability to manage multiple projects, resolve complex issues, and communicate with senior management and non-technical audiences.
• Advanced Word and Excel skills.
• Ability to work in a hybrid arrangement at the Eagan, MN site and travel up to 15%.

Nice to have

• RAC certification.
• Experience with SAP.
• Experience writing 510(k)s and CE technical files.
• Direct people-management experience.
• Knowledge of EPA VOC, Prop 65, FIFRA, OSHA HAZCOM, CPSC, DOT, FDA, or VAWD requirements.

Culture & Benefits

• Health insurance, life and disability insurance, 401(k) contributions, and paid time off for eligible employees.
• Continuing education and training opportunities.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access.
• Focus on inclusion, belonging, professional growth, and providing resources for effective work.