Write submission documents for FDA, Health Canada, Notified Bodies, and other regulatory agencies. Develop responses to questions or deficiency letters from regulatory agencies.
Proactively partner with R&D, Marketing and other groups to confirm the regulatory requirements necessary to place products on international and domestic markets. Develop and approve appropriate technical documents for regulatory submissions in support of the development project.
Develop and maintain Technical Files for CE marking.
Assess regulatory impact of post-market changes on labeling, design, materials, or manufacturing process.
Participate as a member of new product development teams to provide regulatory support to the project.
Identify and implement process improvements and updates to regulatory department SOPs.
Review new regulations for implications for the company and recommend strategy to achieve compliance with requirements.
Participate in ensuring a global regulatory team approach.
REQUIRED EDUCATION AND EXPERIENCE:
Required 3-4 years in regulatory affairs within the medical device industry (IVD experience highly preferred).
Preferred experience in ex-US regulatory submissions.
Preferred experience in writing/maintaining CE Technical Files.
Minimum Bachelor’s degree in a technical discipline required; Master’s Degree in a technical discipline preferred.
Regulatory Affairs Certification (RAC) preferred.
Must be able to work independently and efficiently to complete multiple projects within deadline.