Lead Specialist in Regulatory Affairs
1 week ago
Lead Specialist in Regulatory Affairs
Location: Remote
Contract Type: Long-term
We are seeking a highly skilled professional to join our team as a Lead Specialist in Regulatory Affairs. This role is crucial for ensuring compliance and facilitating the regulatory processes for our innovative medical devices.
Key Responsibilities:- Expertise in In Vitro Diagnostic (IVD) devices and their regulatory pathways.
- Experience with US 510(k) submissions within the past five years.
- Collaborate effectively with cross-functional teams to prepare and write regulatory submissions.
- Demonstrate exceptional technical writing capabilities.
- Exhibit strong communication skills to liaise with various stakeholders.
- This position requires full onsite presence.
- Providing examples of technical writing will be advantageous.
- A Bachelor's Degree in a scientific discipline (Biology, Chemistry, Microbiology, Immunology, Medical Technology, Pharmacy, Pharmacology, Mathematics, Engineering, or related fields) is preferred.
- A Master's degree in a relevant technical area is advantageous.
- Professional certification, such as RAC from the Regulatory Affairs Professionals Society, is a plus.
- A minimum of 5 years of experience in a regulated industry, particularly in medical devices or pharmaceuticals.
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