Regulatory Affairs Specialist

Position Details

• Position Type:
  Full Time / Direct Placement
• Job Location:
  
  Creedmoor, NC
• Benefits:
  Excellent benefits, generous PTO and holiday schedule, generous 401k match, and more
• Compensation: $100, annually depending upon experience
• Drug and background screenings required

Regulatory Affairs Specialist

Regulatory Affairs

Director of QA and RA

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 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.

• 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.

• 5+ years' experience in Regulatory Affairs for EU regulated Medical Device environments.
• Authored multiple technical files, with proven experience in EU MDR technical files.
• Familiarity with FDA, EU MDR, Health Canada, and other international regulatory standards and regulations.
• Knowledge and understanding of the software development lifecycle (SDLC).
• Minimum of a Bachelors' Degree.
• 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.
• Excellent written and oral communication skills.
• Strong documentation skills.
• Understanding of ISO 13485:2016 and ISO 14971:2019.

• RAPS certification – preferred.
• Compliance Quest electronic quality system management experience.

• Provides vital input to the Engineering and Science teams as products are developed for acceptance and submission to the European market.
• Authors EU MDR Technical Files and helps with other international submissions.
• Communication and relationship with other departments is one of mutual respect and cooperation.
• Special Projects assigned for Regulatory to support Research and Development is completed.

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

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

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

Work is regularly performed in office and warehouse environments.

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.

Minimal travel may be required to meet job requirements.

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.

We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.

Job Diva 26-00304