Regulatory Affairs Specialist (Medtech)

TL;DR

Regulatory Affairs Specialist (Medtech): Developing and implementing regional regulatory strategies for resuscitation products with an accent on device approval and compliance. Focus on authoring submittals such as 510(k) and PMAs, managing risk assessments, and supporting cross-functional NPI project teams.

Location: Must be based in Chelmsford, MA

Salary: $85,000.00 - $123,000.00

Company

hirify.global develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally.

What you will do

• Develop and implement regional regulatory strategies for new and sustaining products to ensure device approval.
• Author and prepare submittals for IDEs, 510(k), PMAs, Technical Files, and Design Dossiers.
• Provide regulatory guidance to cross-functional New Product Introduction (NPI) project teams.
• Conduct risk assessments and ensure overall regulatory compliance.
• Coordinate with internal and external resources to meet audit and compliance requirements.
• Monitor current regulations and disseminate strategic information to product teams.

Requirements

• Bachelor's Degree in a relevant Science or Engineering field.
• 0-1 years of experience in Regulatory Affairs, preferably within the medical device industry.
• Proven experience working with electro-mechanical products.
• Strong written and verbal communication skills for interfacing with diverse stakeholders.
• Ability to create detailed action plans and project deliverables.
• Location: Must be based in Chelmsford, MA

Nice to have

• Advanced degree in a relevant field.
• Experience in the electro cardiology or defibrillation/respiratory space.

Culture & Benefits

• Eligibility for an annual bonus based on the company's bonus plan.
• Comprehensive benefits package.
• Opportunity to work in a fast-growing company operating in over 140 countries.
• Culture that values innovation, self-motivation, and an entrepreneurial spirit.