EPM Scientific - Phaidon International
Principal Regulatory Affairs Specialist
EPM Scientific - Phaidon International, Pleasanton, California, United States, 94566
Title:
Principal Regulatory Affairs SpecialistA leading medical device and diagnostics company is seeking a Principal Regulatory Affairs Specialist to support their growing product portfolio. This is an exciting opportunity to join an innovative company working on breakthrough products.Responsibilities:Developing strategies for regulatory approval on a global scale for new and modified productsPrepare regulatory applications for FDA and international agenciesCoordinate, compile, and submit regulatory submissions such as EU dossiers, Premarket notifications, PMA supplements, change notifications, etc.Maintain annual licenses, registrations, and listing informationAct as the subject matter expert (SME) for audits and inspections with internal and external authoritiesReview and edit Ad Promo materialMaintain ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements worldwide are current and up-to-date. Ensure that details of any new or modified regulations are distributed to appropriate team members.Support the product implementation process by creating database (GTS) licenses or reviewing and approving requests for product release.Qualifications:Minimum 5+ years of experience with Class II and/or Class III medical devicesExperience authoring and submitting 510k applications and PMA supplementsRAC CertificationExperience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC)Strong technical writing skillsMust be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and clinical investigationsAbility to travel 5%, including international travel
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Principal Regulatory Affairs SpecialistA leading medical device and diagnostics company is seeking a Principal Regulatory Affairs Specialist to support their growing product portfolio. This is an exciting opportunity to join an innovative company working on breakthrough products.Responsibilities:Developing strategies for regulatory approval on a global scale for new and modified productsPrepare regulatory applications for FDA and international agenciesCoordinate, compile, and submit regulatory submissions such as EU dossiers, Premarket notifications, PMA supplements, change notifications, etc.Maintain annual licenses, registrations, and listing informationAct as the subject matter expert (SME) for audits and inspections with internal and external authoritiesReview and edit Ad Promo materialMaintain ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements worldwide are current and up-to-date. Ensure that details of any new or modified regulations are distributed to appropriate team members.Support the product implementation process by creating database (GTS) licenses or reviewing and approving requests for product release.Qualifications:Minimum 5+ years of experience with Class II and/or Class III medical devicesExperience authoring and submitting 510k applications and PMA supplementsRAC CertificationExperience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC)Strong technical writing skillsMust be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and clinical investigationsAbility to travel 5%, including international travel
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