Regulatory Affairs Specialist
3 days ago
Job Title: Regulatory Affairs Specialist
Company: Intellectt Inc
Job Type: Full-time
Location: Remote
About Us: Intellectt Inc is a leading company in the medical device industry, and we are seeking a highly skilled Regulatory Affairs Specialist to join our team.
Job Summary:
We are looking for a detail-oriented and organized Regulatory Affairs Specialist to support our post market surveillance department. The successful candidate will have experience in related fields, such as medical device or pharmaceutical industries, and will be responsible for determining classification, review, and disposition of adverse events and medically related complaints.
Responsibilities:
- Determine classification, review, and disposition of adverse events and medically related complaints for on-market products.
- Review and analyze data to identify potential causality and make decisions on seriousness and reportability.
- Complete FDA MDR and other outside competent authority regulatory reports.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
Requirements:
- Four-year degree, preferably in the healthcare or science fields; or 2-year degree and relevant experience.
- Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry preferred.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
What We Offer:
Intellectt Inc offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
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