Remote Regulatory Affairs Specialist — Medical Devices (NA)

OrganOx; Alabama; Hybrid; USD 100,000 - 150,000; Full time

Job summary

OrganOx is seeking a Regulatory Affairs Specialist to prepare regulatory submissions for North America and support GMP/ISO compliance. The role is remote with in-person collaboration and will report to the VP of Regulatory Affairs and Quality, North America, working with teams in the UK.

The ideal candidate has at least 3 years’ regulatory submission experience for Class II/III medical devices, strong FDA knowledge, and excellent writing skills.

Qualifications

• BS degree in engineering, life science, or related field.
• At least 3 years' regulatory submission experience for Class II/III medical devices.
• Strong knowledge of FDA processes for medical device compliance.
• Ability to write clear regulatory strategies and submissions.
• Understanding GMP compliance in Quality Control.
• Experience collaborating with Manufacturing, Quality, R&D, Clinical and Marketing.
• Proficient in MS Office; excellent verbal and technical writing skills.
• Ability to work independently.

Responsibilities

• Prepare regulatory submissions (IDE; IDE Supplements; PMA; PMA Supplements) for FDA and Health Canada.
• Interface with FDA and Health Canada on assigned projects.
• Respond to FDA and Health Canada requests for additional information.
• Interact with FDA, Health Canada and/or Notified Body during quality inspections; respond to reports during inspections.
• Keep up with changes to US/Canada regulatory requirements and International Standards related to OrganOx products.
• Communicate regulatory initiatives or changes in medical device law to personnel, customers, subcontractors, regulators, and third parties.
• Review regulatory guidances for assigned projects to ensure compliance and determine required submissions.
• Prepare visualizations and conclusions for presentation to upper management.
• Work with key stakeholders on Regulatory and Quality topics.
• This role requires work at the Giralda office in Madison NJ ~2 days/week; some US/UK travel.

Skills

Regulatory submissions

Regulatory strategies

FDA processes

GMP compliance

Cross-functional collaboration

MS Office

Technical writing

Independent work

Education

BS degree in engineering or life science

Tools

MS Office

Job description

OrganOx is seeking a Regulatory Affairs Specialist to prepare regulatory submissions for North America and support GMP/ISO compliance. The role is remote with in-person collaboration and will report to the VP of Regulatory Affairs and Quality, North America, working with teams in the UK.

The ideal candidate has at least 3 years’ regulatory submission experience for Class II/III medical devices, strong FDA knowledge, and excellent writing skills.