Regulatory Affairs Principal

July 2

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Description

- Develop sound global, regional, and multi-country regulatory strategies for new and modified SaMD medical devices. - Provide regulatory intelligence to aid in market assessments and portfolio planning - Prepare international and domestic submissions/registrations to established timelines and company objectives (e.g.,510(k), Q-submissions, Technical Documentations) - Represent Regulatory Affairs on assigned projects and provide regulatory guidance to the cross-functional teams - Collaborate with cross functional partners in driving and implementing new processes to address non conformances or remediation efforts. - Anticipate regulatory and related obstacles and emerging issues throughout the product life cycle - Interact with regulatory authorities during the development and review process to ensure submission approval - Defining regulatory requirements on device labeling and review labeling content for compliance for global markets - Coordinate with international contacts on product changes, regulatory notifications and registration/license maintenance - Review and approve product design changes to maintain regulatory compliance for significant changes - Author or revise SOPs to improve regulatory compliance of the Quality System - Monitor impact of changing global regulations on submission strategies & registrations - Perform other quality and regulatory-related duties as assigned.

Requirements

- Bachelor’s degree- 8 years of regulatory affairs experience with a Bachelor's degree; 6 years experience with Master's or other advanced degree in a related field - Lead and/or author 510k or MDR submission experience required - Familiarity with global medical device regulations; 21 CFR 820, MDD/CMDR, EU MDR, ASIA PAC, LATAM, etc. - Demonstrated understanding of ISO 13485, ISO 14971, GDPR, HIPAA and other international regulations/directives/standards - Exceptional communication (written and oral) skills - Experience writing content for regulatory submissions. (CER\CEP\Tech Papers\Reports\RBA...) - Willingness to travel when required, up to 5% (Audit Support) - Cross Skilled in QMS - Completing Regulatory Impact Assessments

Benefits

- 5% travel assistance - Cross-skilled in QMS - Completing Regulatory Impact Assessments