Job Description
Mission/
Position Headline:
As the Regulatory Affairs, we ensure fast reliable global access to Advanced Therapies innovations by owning regulatory approvals, translating country-specific requirements actionable guidance, enabling compliant product changes new development projects that support better patient outcomes sustainable business success. We ensure the business revenue of AT by generating the needed market access four products.
Areas of Responsibilties:
Regulatory Affairs:
· Develop execute regulatory strategies fnew products, product changes, product localization, lifecycle management activities aligned with business project milestones.
· Monitanalysis emerging global regulatory standards, translating regulatory requirements compliant products, processes, quality management systems.
· Lead required registrations, submissions, renewals, notifications, maintenance activities throughout the product lifecycle.
· Build maintain effective relationships with competent authorities, regulatory agencies, notified bodies, business partners, internal stakeholders to facilitate regulatory alignment, proactive risk management, timely approvals.
· Drive AT QT global strategy quality targets, process continuous improvement digitalization through the application of data-driven approaches, digital tools, AI-enabled solutions where appropriate.
· Act as a trusted regulatory partner to cross-functional teams, providing regulatory expertise to support innovation, business growth, compliance in global markets.
· Fsenior-level incumbents: lead complex high-risk regulatory topics, provide expert guidance, mentcolleagues, influence cross-site global regulatory practices.
· Misc.
Dimension of Function/Volume:
Act as a trusted regulatory partner throughout the product lifecycle, driving global market access ensuring compliance with applicable regulatory requirements standards. Represent Regulatory Affairs in product development activities, providing regulatory guidance approvals to ensure design, development, lifecycle changes are compliant with regulatory requirements, quality standards, internal procedures.
Contacts
(internal/external):
Interal: Cooperation with project/product team to prepare license submission/update/filing documents. Support provide consult to market access related topics, join the main reviews fthe decisions of milestones.
External: Coolaboralte with competent authorities, external agencies, SHS AT QT RA, AT SZN, cross BL RA, local country RA to align the license strategy/get the license approval. keep contacts with relevant functions of business units of SHS on process, project cooperation.
Education Experience
Experience
· 5+ years of experience in medical device regulatory affairs with strong knowledge of China, USA, global regulatory requirements.
· Proven experience in product registration, regulatory compliance, quality management, audits, product lifecycle support.
· Experience with software-enabled, digital, AI-enabled medical devices is a preferred.
· Digital AI fluency, including practical application of data analytics, automation, AI tools in a regulated environment is a plus
· Excellent stakeholder management communication skills in English Mandarin.
Education
· Bacheldegree above, majin SW, HW, E&E, Biomedical Engineering, data science, computer science , related technical disciplines is preferred.
· Certificate on ISO13485 QMSR/QSR820 CGMP, MDSAP MDR is a plus.
· Certificate/related training on project management, digital technologies, data analytics, cybersecurity, AI, software quality management are considered an advantage.
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