Senior Manager, Regulatory Affairs IVD and Companion Diagnostics, JAPAC
Salary undisclosed
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- Develops device regulatory product strategies and identifies data and information requirements with limited supervision.
- Assists with preparation of submissions, supplements, and correspondence with regulatory authorities, Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
- Seeks expert advice and technical support as required for strategies and submissions.
- Develops device strategies for meetings with regulatory agencies and manages the content and preparation of information packages for pre-meeting submissions
- Represents RA Device on product development teams, Global Regulatory Product Teams, and Pipeline Commercialization Model teams for assigned projects; negotiates with and influences team members to maximize chances for first pass approval of regulatory submissions.
- Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation and guidance and provides updates to organization under limited supervision.
- Develops, implements and documents policies and procedures within the regulatory affairs department under supervision of manager. Participates in initiatives internal to Device RA.
- Represents RA Device on project initiatives with other groups to drive efficiencies across the company.
- Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related subject.
- Preferred Education: Relevant advanced degree preferred.
- Required Experience: 10+ years of industry experience with IVD, companion diagnostics, medical devices, or combination products. 5+ years in quality systems or cross-functional project management.
- Experience working in a complex and matrix environment.
- Strong communication skills, both oral and written. Fluency in Mandarin Chinese preferred.
- Preferred Experience: 10+ years of pre-market regulatory experience in IVD industry. Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required. Specific experience on China CDx regulations and agency interactions preferred.
- Experience developing and implementing successful global regulatory strategies.
- Experience working with Health Authorities
- Develops device regulatory product strategies and identifies data and information requirements with limited supervision.
- Assists with preparation of submissions, supplements, and correspondence with regulatory authorities, Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
- Seeks expert advice and technical support as required for strategies and submissions.
- Develops device strategies for meetings with regulatory agencies and manages the content and preparation of information packages for pre-meeting submissions
- Represents RA Device on product development teams, Global Regulatory Product Teams, and Pipeline Commercialization Model teams for assigned projects; negotiates with and influences team members to maximize chances for first pass approval of regulatory submissions.
- Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation and guidance and provides updates to organization under limited supervision.
- Develops, implements and documents policies and procedures within the regulatory affairs department under supervision of manager. Participates in initiatives internal to Device RA.
- Represents RA Device on project initiatives with other groups to drive efficiencies across the company.
- Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related subject.
- Preferred Education: Relevant advanced degree preferred.
- Required Experience: 10+ years of industry experience with IVD, companion diagnostics, medical devices, or combination products. 5+ years in quality systems or cross-functional project management.
- Experience working in a complex and matrix environment.
- Strong communication skills, both oral and written. Fluency in Mandarin Chinese preferred.
- Preferred Experience: 10+ years of pre-market regulatory experience in IVD industry. Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required. Specific experience on China CDx regulations and agency interactions preferred.
- Experience developing and implementing successful global regulatory strategies.
- Experience working with Health Authorities