Sr. Regulatory Affairs Specialist
Basic Qualifications:
Master’s degree in Regulatory Affairs, Biomedical,
Electrical or Mechanical Engineering or related field and 2 years of experience
in regulatory affairs. Must possess at least 2 years of experience with each of
the following: assessing regulatory impact of product changes; identifying
regulatory requirements for bench, electrical and clinical testing; labeling
and promotional material review for medical devices; post-market regulatory
activities; IEC 60601-1, IEC 60601-1-2 and IEC 62304; Chinese regulatory
submissions for Class II and Class III medical devices; negotiating with
Chinese regulators and local testing centers; technical files, 510(k)
submissions and change notifications for medical devices; 21 CFR 820, ISO13485
and ISO14971; and supporting cross functional groups with regulatory guidance.
