Peyton Resource Group
Overview
Regulatory Affairs Level III (Senior Specialist) Job Summary: Responsible for global product registrations and regulatory compliance across the design, manufacturing, and commercialization of medical devices, including Class I & II devices, software as a medical device (SaMD), and de novo devices. Oversees regulatory approvals, maintains compliance with applicable standards, and supports Quality Management System (QMS) initiatives to ensure product and process adherence to regulatory requirements.
Responsibilities
Develop and execute regulatory strategies to achieve market clearance efficiently.
Prepare, submit, and maintain product registrations, certifications, and approvals to meet U.S., EU, and international requirements. Include 510(k) and/or De Novo submissions for FDA; develop technical documentation to ensure EU MDR compliance; manage international product registration activities aligned with business objectives.
Provide regulatory input for product labeling and marketing materials.
Monitor new and evolving regulatory requirements; communicate business impacts.
Lead or support Corrective and Preventive Action (CAPA) activities.
Provide regulatory input throughout the product lifecycle, including during design control phases.
Partner with cross-functional teams to support timely and compliant regulatory submissions.
Evaluate and document regulatory impacts of design, manufacturing, and process changes.
Ensure updates to product registrations reflect design modifications and QMS changes.
Support internal and external audits, including participation in FDA and notified body inspections.
Prepare regulatory documentation and responses as required.
QMS & Continuous Improvement
Complete required QMS and compliance training.
Provide regulatory expertise to continuous improvement, Lean, and Kaizen initiatives.
Comply with all company policies and procedures.
Perform additional duties as assigned.
Qualifications
Education: Bachelor of Science degree required.
Experience: 5–7 years of regulatory affairs experience in the medical device industry (respiratory device experience preferred).
Proven success leading multiple 510(k) clearances and CE marking projects.
Experience with global regulatory submissions and pathways preferred.
Technical Skills: Strong understanding of the medical device product lifecycle and related regulatory requirements; in-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR; familiarity with ISO 14971 risk management; proficiency in database systems and advanced Microsoft Excel; knowledge of continuous improvement methodologies.
Personal Attributes: Exceptional written and verbal communication skills; able to explain complex regulatory concepts clearly; analytical and critical thinker with strong problem-solving and decision-making abilities; highly detail-oriented and accurate in preparing regulatory documentation.
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Responsibilities
Develop and execute regulatory strategies to achieve market clearance efficiently.
Prepare, submit, and maintain product registrations, certifications, and approvals to meet U.S., EU, and international requirements. Include 510(k) and/or De Novo submissions for FDA; develop technical documentation to ensure EU MDR compliance; manage international product registration activities aligned with business objectives.
Provide regulatory input for product labeling and marketing materials.
Monitor new and evolving regulatory requirements; communicate business impacts.
Lead or support Corrective and Preventive Action (CAPA) activities.
Provide regulatory input throughout the product lifecycle, including during design control phases.
Partner with cross-functional teams to support timely and compliant regulatory submissions.
Evaluate and document regulatory impacts of design, manufacturing, and process changes.
Ensure updates to product registrations reflect design modifications and QMS changes.
Support internal and external audits, including participation in FDA and notified body inspections.
Prepare regulatory documentation and responses as required.
QMS & Continuous Improvement
Complete required QMS and compliance training.
Provide regulatory expertise to continuous improvement, Lean, and Kaizen initiatives.
Comply with all company policies and procedures.
Perform additional duties as assigned.
Qualifications
Education: Bachelor of Science degree required.
Experience: 5–7 years of regulatory affairs experience in the medical device industry (respiratory device experience preferred).
Proven success leading multiple 510(k) clearances and CE marking projects.
Experience with global regulatory submissions and pathways preferred.
Technical Skills: Strong understanding of the medical device product lifecycle and related regulatory requirements; in-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR; familiarity with ISO 14971 risk management; proficiency in database systems and advanced Microsoft Excel; knowledge of continuous improvement methodologies.
Personal Attributes: Exceptional written and verbal communication skills; able to explain complex regulatory concepts clearly; analytical and critical thinker with strong problem-solving and decision-making abilities; highly detail-oriented and accurate in preparing regulatory documentation.
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