Regulatory Affairs Specialist (medical device)- NAMIC at Medline Industries, Inc. in Glens Falls, New York

Job Description:

Under general supervision, ensure the content, context, organization and overall quality of all regulatory documentation is adequate and sufficient to meet all regulatory requirements, commitments and agreements (labeling, licensing, registration, listing and/or submission for clearance or approval Medline facilities and/or product).

• Support International requests.


• Prepare and maintain Technical Documentation (EU Technical Files).


• Research and prepare recommendations on regulatory pathways for new projects.


• Attend project team meetings and provide regulatory support.


• Assist in the review and approval of labeling and advertising materials.


• Determine the requirements for and complete Medline product submissions for regulatory authority clearance or approval (to market a new product as a medical device by working with vendors, internal customers and consultants as needed.


• Communicate requirements of regulations to internal or external customers, or to vendors.


• Initiate or maintain relevant procedures or SOP's, updating as needed and training when required.


• Maintain department databases, logs and files.

Education/Relevant Work Experience

• Bachelor's Degree (biology, chemistry, engineering, information technology, pharmacology, quality, toxicology, clinical sciences) AND at least 2 years of experience in regulatory, quality assurance, research and development/support, scientific affairs, operations, or related area.

OR

• High school diploma or equivalent AND at least 5 years of experience in regulatory, quality assurance, research and development/support, scientific affairs, operations, or related area.

Additional

• Experience applying an understanding of the current Regulatory environment and demonstrating the ability to perform within.


• Experience applying knowledge of FDA regulations and guidelines on advertising and promotional material.


• Experience evaluating information to determine compliance with standards, laws, and regulations.


• Advanced skill level in Excel, Word.

PREFERRED QUALIFICATIONS:

Relevant Work Experience

• At least 1 year of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

Additional

• Experience applying knowledge of the CFR, FDA/ICH guidelines and cGMP's as they pertain to medical devices.


• Experience applying knowledge of FDA regulations and guidelines on advertising and promotional materials.


• Proficient in the following computer software application: Microsoft Office (PowerPoint)

Apply Now