Regulatory Affairs Specialist I

Getinge • Boston, MA

4d • $65,000 - $82,000

About The Position

The Regulatory Affairs Specialist I will support global regulatory compliance activities for medical devices across Paragonix’s product portfolio. This role will assist in preparing and maintaining regulatory submissions, coordinating documentation updates, and ensuring compliance with international and domestic regulatory requirements. The Specialist I will collaborate cross‑functionally to support sustaining engineering, quality systems, and product lifecycle activities while gaining foundational experience in global regulatory affairs.

Requirements

• Bachelor's degree in technical or scientific discipline; Master's degree or professional certification in Regulatory Affairs is a plus.
• Strong organizational and follow-up skills, as well as attention to detail
• Ability to work within a team and as an individual contributor in a fast-paced environment
• Ability to multitask, prioritize work, and meet deadlines in timely manner.
• Ability to work collaboratively across different departments.
• Excellent communication and interpersonal skills
• Excellent oral and written communication skills in English.
• Able to travel domestically and internationally as required (<10%)
• Able to work in the US without sponsorship now or any time in the future

Nice To Haves

• Master's degree or professional certification in Regulatory Affairs

Responsibilities

• Lead preparation and maintenance of international registrations and renewals.
• Maintain Rimsys (regulatory management system) to ensure accuracy and completeness of registration and UDI records.
• Coordinate label updates and translation requests ensuring alignment with regulatory requirements.
• Perform sustaining change assessments to evaluate regulatory impact of manufacturing, design, or documentation changes.
• Monitor changes in applicable standards and regulations and perform gap analyses as needed.
• Support tracking and communication of changes to cross functional teams
• Support various external or internal regulatory requests under guidance from senior regulatory staff.
• Assist in drafting and updating regulatory procedures, work instructions, and related documentation.
• Support regulatory quality objectives and continuous improvement.

Benefits

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees