This position will be responsible for global adverse event reporting, world-wide regulatory submissions and ensuring compliance with all the required regulations for assigned projects.
Summary of Position with General Responsibilities:
•Develop and implement regulatory strategies for Class III devices through national authorities, physicians, consultants and internal team members
•Prepare regulatory submissions of world-wide regulatory applications (IDE, PMA, Design Dossier, OUS Clinical submission, export submission, etc), as well as internal regulatory file documentation
•Act as company representative, developing and maintaining positive relationship with regulatory authorities through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review
•Participate in regulatory agency and Notified Body audits
•Ensure in-house compliance with regulations and update on submission status
•Ensure and sign-off on design and manufacturing changes for compliance, proper documentation, and reported per applicable regulations
•Participate as core regulatory team member on development teams
•Conduct Pre and Post Market global adverse event reporting
•Minimum of 4 years Regulatory Affairs medical industry experience (medical device, pharmaceutical and/or combination drug/device regulatory submissions)
•Experience with regulatory oversight and filing of reportable pre- and post-market adverse events and vigilance reports.
•Thorough understanding of FDA and European regulations, including IDE, PMA, & MDD
•Proficiency with PC computer and Microsoft Office software
Additional Desirable Qualifications Skills and Knowledge:
•Excellent written and oral communication and technical writing skills
•Strong organizational and interpersonal skills
•Ability to effectively manage a wide range of projects with shifting priorities
•Able to manage complex problems/projects by exercising independent decision making and analytical thinking skills
•Technical knowledge of interventional vascular devices, related medical procedures and associated medical terminology preferred
•Experience with Asia-Pacific and Latin America international regulatory submissions a plus
•Ability to work independently with minimal supervision
•Experience with regulatory oversight of CMC issues and related regulatory submissions preferred
•Experience and proficiency with pharmacology and toxicology related submissions a plus
Education and/or Experience:
Bachelors of Science degree or equivalent strongly preferred
While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...