Regulatory Affairs Specialist
13 hours ago
**Job Summary**
We are seeking a highly motivated Regulatory Affairs Specialist to join our team at ZipRecruiter.
The ideal candidate will have over 7 years of experience in regulatory affairs, with expertise in MDR, ISO13485, and UK MDR. They will be responsible for overseeing the development and management of technical files, dossiers, and regulatory documents for medical devices and pharmaceuticals.
Key Responsibilities:
- Collaborate with Notified Bodies to ensure FDA and FDR approval.
- Provide regulatory guidance and support to ensure compliance with EU regulations.
- Develop and implement EU regulatory strategies to meet product requirements.
- Manage project assignments for investigational, new, and marketed products.
- Liaise with government agencies and gather regulatory intelligence.
Requirements:
- Bachelor's degree in Life Sciences or related field.
- At least 7 years of experience in regulatory affairs, preferably in a Medical device business.
- Expert knowledge of MDR, ISO13485, and UK MDR.
- Experience interacting with Notified/Approved Bodies.
- Ideal experience within orthopedics or surgical devices.
Compensation: $100,000 - $120,000 per year, depending on experience.
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