Job Description

CS Medical

Job Title:  Regulatory Affairs Specialist

Department or Division:  Regulatory Affairs

Reports To:  Director of QA and RA

JOB TASKS, DUTIES, AND RESPONSIBILITIES

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. 

JOB DUTIES: 
 

• 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.

MINIMUM QUALIFICATIONS

• 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

PREFERRED QUALIFICATIONS

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

Accountabilities
 

LOCATION

This position will be based at our Creedmoor, NC office.

Terms of employment

This is a full-time, salaried, exempt position.  

HOURS

The general hours shall be Monday – Friday, 8:00am to 5:00pm with an hour break for lunch.

Work Environment

Work is regularly performed in office and warehouse environments.

Physical Demands  

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  The employee is frequently required to sit.  The employee is occasionally required to stand and/or walk.  The employee must occasionally lift, carry, push or pull up to 20 pounds.  

Travell

Minimal travel may be required to meet job 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.  

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.