Medical Device Regulatory Associate Needed!
Highly successful, mid-sized Medical Device manufacturer is seeking a Regulatory Associate. Located in northern, GA, this company champions a collaborative environment with a broad portfolio of products. They have continued to thrive for over 20 years and believe the patient's success is their greatest achievement. They have launched several new products over the last 3 years and have sustained growth during the global pandemic because of their flexibility in adjusting to the needs of the market.
Benefits & Features:
An array of medical device product types will provide numerous opportunities to diversify your skillset across different delivery systems and industries. Big ideas and a vision to share with project and leadership teams who are quality-centric and innovative in order to meet company's goals.
The Role You'll Play:
- Product documentation, risk assessments, and registrations
- Provide regulatory guidance for junior regulatory staff, project teams and leadership team for ISO 13485, 15223, 10993-1
- SME for biocompatibility, necessary clinical data and studies for US, EU, CE marking, MDR, Japan, China, Canada & Australia regulations
- Champion continuous quality improvements for international compliance
- Create & maintain product documents, standards, and regulations
The Ideal Candidate will have:
- Bachelor’s degree with 5+ years’ experience in international regulatory submissions
- RAPS Certification and in-depth knowledge of global medical device regulations and standards
- Excellent verbal and written communication skills and a creative quality-centric approach to risk assessments
If qualified and interested, please share your resume for consideration.