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Regulatory Affairs Specialist II
- Posted 18 September 2024
- LocationSan Diego
- Job type Permanent
- Reference204062
- Contact NameMelody Lam
Job description
We’re hiring a Regulatory Affairs Specialist to work hybrid-onsite at our San Diego, CA office!
This role will support Regulatory post-market sustaining and operations management for medical device hardware, software, and accessories. Responsible for ensuring medical device compliance with all global applicable regulations for regulatory projects to meet corporate objectives. Fosters collaboration with key functional groups in Quality, Engineering, Marketing, Product Development, Manufacturing and Clinical Operations to educate and gain alignment of global regulatory strategies. Prepares, reviews, and submits applications and other filings to various regulatory agencies. Represents the Regulatory Affairs department as a member of project teams, certain boards, and as part of other meetings as the need arises.
Responsibilities:
• Provides regulatory affairs support for all aspects of product development and manufacturing.
• Reviews, approves, and documents changes to devices and determines regulatory strategies for each change.
• Evaluate proposed engineering, manufacturing, labeling and quality system changes and perform global regulatory impact assessment for regulatory filings and approvals.
• Prepares letters-to-file or change notices as needed.
• Responsible for regulatory compliance activities such as unique device identifier (UDI) implementation, quality system changes, manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc.
• Ensures compliance with applicable domestic and international regulations related to Risk Management and Medical Device Reporting.
• Independently interacts with various departments throughout the company with future regulatory submissions in mind and to ensure compliance.
• Assists in preparing regulatory submissions for new product clearances/approvals including 510(k)s, dossiers, technical files, etc.
• Assists in hosting inspections from various regulatory agencies.
• Takes an active role in both internal/external audits.
• Keeps informed of current regulations, standards, policies, and guidance that impact the company’s regulatory methods.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
Position requirements:
• Bachelor's degree required, Master’s degree preferred.
• 2+ years of experience working in an FDA regulated Medical Device or Diagnostic area.
• Regulatory Affairs Certificate preferred.
• Demonstrated experience with medical device life cycle and change management
• Demonstrated ability to: work independently, quickly, accurately, follow instructions and schedules, and handle multiple priorities.
• Excellent technical writing, editing, and proofreading skills.
• Prior experience with SaMD, MDDS, AI/ML, non-SaMD, and Digital Healthcare is preferred.
• Skilled with MS Office applications, Adobe Acrobat, electronic document management systems, and other computer-based applications.
• Demonstrated knowledge of US FDA, EU MDR and Canadian regulations and guidance’s.
• Experience supporting manufacturing operations, preferredt
This role will support Regulatory post-market sustaining and operations management for medical device hardware, software, and accessories. Responsible for ensuring medical device compliance with all global applicable regulations for regulatory projects to meet corporate objectives. Fosters collaboration with key functional groups in Quality, Engineering, Marketing, Product Development, Manufacturing and Clinical Operations to educate and gain alignment of global regulatory strategies. Prepares, reviews, and submits applications and other filings to various regulatory agencies. Represents the Regulatory Affairs department as a member of project teams, certain boards, and as part of other meetings as the need arises.
Responsibilities:
• Provides regulatory affairs support for all aspects of product development and manufacturing.
• Reviews, approves, and documents changes to devices and determines regulatory strategies for each change.
• Evaluate proposed engineering, manufacturing, labeling and quality system changes and perform global regulatory impact assessment for regulatory filings and approvals.
• Prepares letters-to-file or change notices as needed.
• Responsible for regulatory compliance activities such as unique device identifier (UDI) implementation, quality system changes, manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc.
• Ensures compliance with applicable domestic and international regulations related to Risk Management and Medical Device Reporting.
• Independently interacts with various departments throughout the company with future regulatory submissions in mind and to ensure compliance.
• Assists in preparing regulatory submissions for new product clearances/approvals including 510(k)s, dossiers, technical files, etc.
• Assists in hosting inspections from various regulatory agencies.
• Takes an active role in both internal/external audits.
• Keeps informed of current regulations, standards, policies, and guidance that impact the company’s regulatory methods.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
Position requirements:
• Bachelor's degree required, Master’s degree preferred.
• 2+ years of experience working in an FDA regulated Medical Device or Diagnostic area.
• Regulatory Affairs Certificate preferred.
• Demonstrated experience with medical device life cycle and change management
• Demonstrated ability to: work independently, quickly, accurately, follow instructions and schedules, and handle multiple priorities.
• Excellent technical writing, editing, and proofreading skills.
• Prior experience with SaMD, MDDS, AI/ML, non-SaMD, and Digital Healthcare is preferred.
• Skilled with MS Office applications, Adobe Acrobat, electronic document management systems, and other computer-based applications.
• Demonstrated knowledge of US FDA, EU MDR and Canadian regulations and guidance’s.
• Experience supporting manufacturing operations, preferredt
