For The Candidates

Assisting in developing regulatory strategies for new and/or modified products. 

Preparing regulatory submissions for U.S. FDA, including 510(k)'s and PMA’s. 

Preparing technical documentation to demonstrate compliance with applicable U.S Federal medical Device/IVD Regulations.

Participating on project teams and providing regulatory information/advice to the team

Reviewing labeling and promotional materials. 

Participating in developing clinical study designs, clinical protocols, clinical data analysis, and preparing clinical reports.  

Other duties may be assigned. 

TASKS

Assisting in developing regulatory strategies for new and/or modified products. 

·         

·         

Participating on project teams and providing regulatory information/advice to the team. 

·         

·         

Preparing regulatory submissions for U.S registration, including 510(k)'s and PMA’s. 

·         

·         

Reviewing labeling and promotional materials. Participating in developing clinical study designs, clinical protocols, clinical data analysis, and preparing clinical reports. 

·         

·         

Other duties may be assigned. 

MINIMUM QUALIFICATIONS

Required:

• Minimum of 3 – 5 years experience in the medical, pharmaceutical or biology industry required (IVD experience strongly preferred)
• Minimum of 1 year of Regulatory experience
• A demonstrated and proven track record of FDA submissions including 510(k)’s and PMA’s.
• Working knowledge of FDA medical device/IVD regulation

Preferred:

·        MS in a science field or equivalent

·        3 – 5 years experience in IVD products.

KNOWLEDGE

• Working knowledge of FDA medical device/IVD regulation. .
• Knowledge of 501(k) submission process.

SKILLS

• Strong technical writing ability
• Strong interpersonal and communication skills (verbal and written) with internal and external customers.
• Demonstrated organizational and planning abilities. 
• Ability to multi task and work in a fast paced environment.

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