Regulatory Affairs Specialist

Air Clean Systems • Creedmoor, NC

19h • Onsite

About The Position

The Regulatory Affairs Specialist is responsible to develop and execute the regulatory strategy for new product development, design changes, and field safety corrections, with a primary focus on EU MDR technical file submissions.

The Regulatory Affairs Specialist will help CS Medical navigate the industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance in the EU, working closely with healthcare regulatory bodies globally. The Regulatory Affairs Specialist helps interpret simple internal and external regulatory challenges and recommends best practices to improve products, processes or services to meet all regulatory requirements.

Requirements

• You’ve acquired a minimum of 5+ years’ experience in Regulatory Affairs for EU regulated Medical Device environments.
• You have authored multiple technical files, with proven experience in EU MDR technical files.
• Your skills include familiarity with FDA, EU MDR, Health Canada, and other international regulatory standards and regulations.
• You have knowledge and understanding of the software development lifecycle (SDLC).
• You have a minimum of a Bachelors’ Degree.
• You have the proven ability to build strong relationships with internal and external stakeholders at all levels, sharing knowledge, providing regulatory insights, and ensuring alignment with regulatory requirements.
• You have excellent written and oral communication skills.
• You have strong documentation skills.
• You understand ISO 13485:2016 and ISO 14971:2019

Nice To Haves

• RAPS certification- preferred.
• ComplianceQuest electronic quality system management experience

Responsibilities

• Author EU MDR technical files and will contribute to other international regulatory submissions.
• Participates in strategic product development, design solutions starting from concept phase to product delivery phase and provide regulatory guidance throughout design and development.
• Act as a regulatory Subject Matter Expert (SME) on various aspects and provide strategic guidance to management and project teams. Able to manage special projects across a spectrum of product lines.
• Monitor global regulatory landscapes and guide cross-functional teams on implementation of regulation changes.
• Communicate new and coming changes, facilitate/assist with interpretation to guide product and business compliance with regulatory requirements.

Benefits

• Compensation package includes health insurance, dental insurance, vision insurance, short term disability, life insurance and Teladoc following an introductory period.
• The Company offers a 401K plan with employer contribution.
• The Company also offers paid time off and paid holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees