Atrion Medical Products, Inc. is a long established Medical device manufacturer in Arab, Alabama with an immediate need of a Senior Regulatory Affairs Specialist.

Bachelor’s Degree or higher in a Business-related field and a minimum of 5 years of experience with FDA and ISO Regulations and Customer interface in a manufacturing environment are required. Medical manufacturing preferred. 

The Senior Regulatory Affairs Specialist will report to the Director of Regulatory and Quality, and assist in maintaining Regulatory compliance for Atrion Medical’s FDA Class 2/ EU MDR Class Is/Im devices.

Duties and Responsibilities:
•    Maintain awareness of regulatory guidelines and assess impact any changes may have on the company and our products.
•    Ensure the requirements of all applicable regulations and industry standards are implemented and maintained.
•    Responsible for technical filings as required.
•    Assist in development and creation of policies and procedures to ensure regulatory compliance.
•    Prepare pre-market notifications to the FDA.
•    Other duties as assigned by Executive management.
•    Adhere to all Atrion policies including safety, attendance, and personal hygiene requirements per the Atrion Employee Handbook.  

Qualifications/Skills:
•    Proficiency in Microsoft applications including Outlook, Excel, Word, PowerPoint, Teams and Project.
•    Excellent working knowledge of FDA 21 CFR Part 820; ISO 13485:2016; EU Medical Device Regulation (EU 2017/745)/MDD 93/42/EEC; other international regulations as applicable.
•    Excellent verbal and written communication skills required. 
•    Ability to work on multiple projects simultaneously.

Atrion Medical offers BCBS medical/dental insurance, 401K with company match, FSA, paid vacation and other benefits.  Salary will be based on education and/or experience. Please submit resume to:

Atrion Medical Products, Inc.
1426 Curt Francis Road NW
PO Box 564
Arab, Alabama  35016
resumes@atrionmedical.com
Phone: (256) 506-3659
Fax: (256) 586-3811

Atrion Medical Products, Inc. is an Equal Opportunity Employer