Sr. RA Specialist

About the role

Noah Medical is seeking a Senior Regulatory Affairs Specialist to support the development and execution of global regulatory strategies for new and existing medical devices. This role requires a strong background in medical device regulatory affairs, with experience in preparing and supporting FDA 510(k) submissions and international registrations.

Responsibilities

• Develop and execute global regulatory strategies for new and existing medical devices.
• Provide regulatory guidance to cross-functional teams throughout product development, design changes, and sustaining engineering activities.
• Assess regulatory impact of product, process, labeling, software, and manufacturing changes.
• Prepare and submit regulatory submissions including FDA 510(k)s, international registrations, technical documentation, and other regulatory filings as required.
• Support compilation and maintenance of Design and Development Files (DDF), Technical Documentation, and regulatory submission dossiers.
• Carefully track submission status and ensure timely responses to regulatory inquiries.
• Maintain product registrations, licenses, and regulatory approvals.
• Monitor and interpret evolving regulatory requirements and standards, including FDA, EU MDR, ISO 13485, MDSAP, and other applicable regulations.
• Collaborate with Quality, Product Development, and Manufacturing teams to support regulatory objectives.
• Support complaint investigations, CAPAs, post-market surveillance, and field actions from a regulatory perspective.
• Participate in management reviews and regulatory compliance reporting activities.
• Monitor industry trends, regulatory changes, guidance documents, and standards updates.
• Communicate regulatory changes and assess business impact.
• Recommend actions to maintain compliance and support business objectives.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related technical discipline.
• Advanced degree preferred.
• 5+ years of Regulatory Affairs experience within the medical device industry.
• Experience preparing and supporting FDA 510(k) submissions.
• Experience supporting international registrations and regulatory submissions preferred.
• Working knowledge of medical device development processes and design controls.
• Experience with Class II and/or Class III medical devices preferred.
• Strong knowledge of: FDA 21 CFR Part 820 and applicable FDA regulations, EU MDR (2017/745), ISO 13485, ISO 14971 Risk Management, MDSAP requirements, Medical device labeling requirements.
• Regulatory Affairs Certification (RAC) preferred.
• Experience with software-enabled medical devices and cybersecurity submissions preferred.
• Experience supporting global markets including EU, Canada, Australia, and Asia-Pacific regions.
• Experience interacting directly with FDA, notified bodies, and international regulatory agencies.
• Strong project management and organizational skills.
• Excellent written and verbal communication skills.
• Strong analytical and problem-solving abilities.
• Ability to work independently with minimal supervision.
• Proficiency with Microsoft Office and electronic Quality Management Systems (eQMS).

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related technical discipline.
• Advanced degree preferred.
• 5+ years of Regulatory Affairs experience within the medical device industry.
• Experience preparing and supporting FDA 510(k) submissions.
• Experience supporting international registrations and regulatory submissions preferred.
• Working knowledge of medical device development processes and design controls.
• Experience with Class II and/or Class III medical devices preferred.
• Strong knowledge of: FDA 21 CFR Part 820 and applicable FDA regulations, EU MDR (2017/745), ISO 13485, ISO 14971 Risk Management, MDSAP requirements, Medical device labeling requirements.
• Regulatory Affairs Certification (RAC) preferred.
• Experience with software-enabled medical devices and cybersecurity submissions preferred.
• Experience supporting global markets including EU, Canada, Australia, and Asia-Pacific regions.
• Experience interacting directly with FDA, notified bodies, and international regulatory agencies.
• Strong project management and organizational skills.
• Excellent written and verbal communication skills.
• Strong analytical and problem-solving abilities.
• Ability to work independently with minimal supervision.
• Proficiency with Microsoft Office and electronic Quality Management Systems (eQMS).

Skills

• Experience with FDA 21 CFR Part 820 and applicable FDA regulations.
• EU MDR (2017/745) knowledge.
• ISO 13485 and ISO 14971 Risk Management.
• MDSAP requirements.
• Medical device labeling requirements.
• Software-enabled medical devices and cybersecurity submissions.
• Experience supporting global markets including EU, Canada, Australia, and Asia-Pacific regions.
• Experience interacting directly with FDA, notified bodies, and international regulatory agencies.

Benefits

• Competitive salary
• Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
• Equity & Bonus Program
• Life Insurance (company paid & supplemental)
• Disability insurance
• Mental health support through medical insurance programs
• Legal and Pet Insurance
• 12+ paid holidays, Flexible Time Off + Sick Time
• Paid parental leave
• In-office snacks and beverages
• In-office lunch stipend
• On-demand online training and book reimbursement
• Learning & Development Opportunities
• Team building and company organized social and celebration events

Pay

The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: