Regulatory Affairs Specialist II (Medtech)

TL;DR

Regulatory Affairs Specialist II (Medtech): Developing and executing regulatory strategies for complex medical device projects with an accent on compliant submissions to regulatory authorities. Focus on managing FDA (510k, PMA) and EU MDR documentation, ensuring adherence to ISO 13485 and Quality System Regulations.

Location: Hybrid (Merrimack, NH, US)

Salary: $62,837 annually

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Develop and compile materials and documentation for compliant submissions to regulatory authorities.
• Determine accurate regulatory information and deliver detailed global assessments and timelines.
• Coordinate activities related to EuMDR, PMAs, 510(k) premarket submissions, and IDEs.
• Review and disposition labeling, promotional materials, and product modifications.
• Support engineering changes in compliance with Quality Systems Regulation (CMDR) and international laws.
• Participate in special projects including CAPA and corporate initiatives.

Requirements

• Bachelor's degree in a scientific or engineering discipline.
• 2 years of experience in regulatory affairs or related fields.
• Working knowledge of ISO 13485, EU MDD, EUMDR, and 21 CFR Part 820.
• Familiarity with FDA Consensus Standards and Guidance for medical devices.
• Proficiency in MS Office (Word, Excel, Outlook).
• Must be able to work in a hybrid schedule in Merrimack, NH.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401k plan with company match.
• Paid Time Off and wellness initiatives.
• Tuition reimbursement and parental/caregiver leave.
• Life and disability insurance.