Regulatory Submissions Lead — Medical Devices

Charter Medical; Winston-Salem (NC); Presencial; USD 90 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Generous Paid Time Off

Paid Breaks

Annual Bonuses

401k with excellent company match

Health Insurance with multiple plans

Paid Short Term and Long Term Disabled

Resumo da oferta

Charter Medical in Winston-Salem, NC, is seeking an experienced Regulatory Affairs professional to drive submissions and compliance for medical devices across US and international markets. You will coordinate 510(k) filings, EU MDR technical files, and international registrations, while keeping teams aligned with evolving regulations.

The role requires strong communication, cross-functional collaboration, and a solid grasp of FDA requirements (21 CFR Parts 820, 803, 806, 807) and ISO 13485.

Qualificações

• Bachelor’s degree or higher in life sciences, engineering, or related field.
• 3–5 years regulatory affairs in the medical device industry.
• Knowledge of US FDA regulations including 21 CFR Parts 820, 803, 806, and 807.
• Experience with ISO 13485 quality management system requirements.
• Regulatory Affairs Certification (RAC) preferred.

Responsabilidades

• Prepare and submit regulatory documents to obtain market approvals (510(k), EU MDR, international submissions).
• Maintain Technical Documentation and Declarations of Conformity for CE-marked products under EU MDR 2017/745.
• Prepare and maintain US FDA product listings and establishment registrations.
• Monitor regulatory developments and communicate updates to internal teams.
• Collaborate with marketing, R&D, and operations on regulatory changes and design controls.

Conhecimentos

Regulatory affairs

FDA regulations

Communication skills

Cross-functional collaboration

Global regulatory experience

Formação académica

Bachelor’s degree in life sciences or engineering

Regulatory Affairs Certification (RAC)

Descrição da oferta de emprego

Charter Medical in Winston-Salem, NC, is seeking an experienced Regulatory Affairs professional to drive submissions and compliance for medical devices across US and international markets. You will coordinate 510(k) filings, EU MDR technical files, and international registrations, while keeping teams aligned with evolving regulations.

The role requires strong communication, cross-functional collaboration, and a solid grasp of FDA requirements (21 CFR Parts 820, 803, 806, 807) and ISO 13485.