Job Description
The Stakeholders
The following are the key stakeholders for this position:
- Internal: APAC (TW/HK/ANZ/MY) Commercial, Research and Development, Clinical and Medical Affairs, Global Quality Assurance and Production Site Quality Assurances, Marketing, Global Key Accounts, Supply Chain Management, Legal & Compliance, Global/regional RA team, Human Resource, Finance
- External: Regulators and Trade Associations including TW FDA, HK MDD, AU TGA, MY MDA and distributors, regulatory consultants and Global Key Accounts
Major Responsibilities
- Responsible for regulatory strategies plans, submission, and approval of marketing authorization applications for all new products and life cycle management of marketed products in cluster countries.
- Responsible for maintaining records of regulatory submissions (in Agatha database system) and communications with the relevant regulatory agencies.
- Develop and maintain excellent working relationships with health authorities; identify regulatory risks for investigational and marketed products and develop strategies to minimize those risks.
- Monitor and provide regulatory intelligence on new regulations, guidance and standards which impact medical devices in cluster countries.
Key Deliverables(the main deliverables expected in the first 18-24 months)
- Work, train and support partners inside Hoya, enabling them to create documentation that will support regulatory submissions and compliance.
- Manage the review of regulatory submission documents for completeness and quality in accordance with cluster regulatory agency requirements and standards.
- Provide functional and technical guidance with respect to submission of pre/post market applications and marketing applications.
- Manage and maintain regulatory related information including relevant logs, trackers and archives of regulatory submissions, correspondences, and into Agatha license database.
Qualifications
Education:
- Bachelor's degree or above, preferably in life science or medical engineering
Experience
- Strong knowledge of regulatory requirements for TW QSD requirement and Class I, II medical devices in TW/HK/MY/ANZ (knowledge of ophthalmology products desirable)
- Demonstrated flexibility while ensuring solid execution and compliance.
- Expertise in the development of strategic regulatory affairs plans
- A track record of successful execution of regulatory submissions and ability to drive approvals for medical devices within targeted timelines
- Proven ability to prepare training materials and deliver information to diverse audiences
Knowledge and hard/soft skills
- High energy, collaborative mindset and experience initiating and leading organizational change
- Strong communication, interpersonal, and consultative skills.
- Ability to monitor and interpret external RA regulatory changes (e.g., EU MDR, TFDA regulation updates, UDI guidelines).
- Demonstrated commitment to RA compliance.
- Excellent command of English for written and verbal communication, with sensitivity to cultural diversity.
Behavioral attributes
- Initiative, proactiveness, and independence
- Willingness to embrace challenges
- Strong business orientation
Mobility
Willingness to travel nationally and internationally for up to 20% of the time on average
