The Regulatory Affairs Specialist is located at C.R. Bard Medical Division in Covington, GA.
The Regulatory Affairs Specialist is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team.
+ Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)
+ Prepare 510(k)s, IDEs, PMA and/or international submissions as required
+ Assist in technical interface with FDA and international reviewers and respond to questions
+ Provide the appropriate information to support international product registrations
+ Provide timely review of product labeling and marketing claim for regulatory compliance; approve as directed
+ Provide support required for CE marking activities, including preparation and maintenance of product technical files
+ May provide direction of other personnel to accomplish duties
+ Knowledgeable of the U.S. and European medical device regulations
+ Excellent written and verbal communication skills
+ Self-motivated and able to work independently, having the ability to take ownership of her/his responsibilities
+ Able to prioritize and handle several projects concurrently
+ Technical writing skills and be proficient at compiling successful submissions for the appropriate audience
+ Able to provide leadership and mentoring skills to less experienced regulatory personnel
+ Able to maintain confidentiality in dealing with regulatory and clinical documentation
Must have command of the English language.
Should have mathematical skills commensurate with educational background and necessary for describing and summarizing laboratory and/or clinical data in product registration submissions.
Must demonstrate the ability to plan and complete regulatory pathway determinations, product registration submissions and other documentation.
+ BS in a scientific discipline with 1-3 years employment in the areas of project registration, compliance or quality systems; or
+ Combination of education and experience determined to be equivalent
+ Regulatory Affairs Certification (RAC) desired
+ Must be able to operate computer and office equipment as needed
+ Must be able to travel via airlines as needed
Traditional office environment
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.