BD (Becton, Dickinson and Company) Associate Regulatory Affairs Specialist in Covington, Georgia
Bard has joined BD, together advancing the world of health. BD Urology & Critical Care, formerly Bard Medical, is looking to fill the position of Associate Regulatory Affairs Specialist located in Covington, GA.
The Associate Regulatory Affairs Specialist is responsible for managing compliance activities associated with global regulatory requirements for Medical Affairs. The specialist may work independently or as part of a larger team in the execution of assigned projects. The specialist will also provide product technical expertise and assist regulatory and clinical management in regulatory activities, including assessments, strategies and technical file documentation.
Research clinical evidence requirements for regulatory requirements
Assist in technical interface between the clinical scientists, research and development, regulatory specialist, marketing, and medical affairs
Coordinates or assists in the development of Clinical Evaluation Plans
Responsible for sorting, organizing, and summarizing clinical data for regulatory requirements, and ensuring compliance to appropriate templates
Ensure compliance with internal standards, policies and procedures, Good Clinical Practice, and local, regional, and federal regulations
Must be able to maintain confidentiality in dealing with regulatory and clinical documentation
Strong interpersonal skills in the areas of written and verbal communication
Must be a team player
Must be able to prioritize and handle multiple projects concurrently
Must be self-motivated, work independently and have the ability to work with minimal supervision
Must be computer literate, proficient in Microsoft Word and Excel, desired
Must be results-oriented, able to prioritize work and meet deadlines while delivering high quality outcome
Must be able to research technical topics (product materials and attributes)
Must have well-developed analytical, problem-solving, and decision-making skills, leveraging both logic and creativity
Bachelor’s Degree (Engineering or Life Sciences strongly preferred - Animal Science, Biology, Physiology, Nursing, Medical Technology) with 1 year of experience in medical device/FDA regulated industry or Associate degree in an engineering or scientific discipline with 3-5 years of experience in medical device/FDA regulated industry
Regulatory Affairs Certification (RAC) desired
Experience with European Device Regulations (EU MDR) desired
Must be able to operate computer and office equipment as needed
Must be able to travel via airlines as needed
Ability to occasionally lift objects up to 25 lbs.
Traditional office environment
Career Level: entry level
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
Street: 8195 Industrial Blvd.
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.