Technical Lead

\n \n \n Seeking a Regulatory Affairs professional with global/MDR or MDD (Medical Device Directive) labeling experience ? Experience with CE Marking and European Union Medical Device Regulations ( EU MDR) ? Experience with Redlining medical device product labeling to country requirements ? Development of labeling requirement specifications, requirements traceability ? Subject matter expert in MDD/MDR product labeling ? Command of labeling standards such as ISO 15223, ISO 60601-1 What are your top three to five soft skill wants? ? An active listener with strong verbal and written communication skills ? Negotiation skills ? Requires Problem-solving skills for creative thinking to find solutions and have the ability to make sounds risk based decisions ? High level of business acumen ? Ability to identify and communicate potential compliance issues and escalate as necessary. ? Self-starter with strong time management skills \n Solidworks