The Company
The HOYA Group: Founded in 1941 in Tokyo, Japan, HOYA Corporation is a global technology and med-tech company and a leading supplier of innovative high-tech and medical products. HOYA's divisions and business units research and develop products utilized in the healthcare and information technology fields.
In the healthcare field, we provide medical device products such as eyeglasses, medical endoscopes, contact and intraocular lenses, orthopaedic implants, surgical/therapeutic devices and medical device reprocessing and disinfection solutions. In the information technology field, we provide products such as optical lenses, photomasks, and blanks used in the manufacturing process for semiconductor and LCD/OLED devices, text-to-speech, human resources, and other software solutions and critical components for the mass memory and cloud storage industries. With over 150 offices and subsidiaries worldwide, HOYA currently employs a multinational workforce of 37,000 people.
HOYA Vision Care: As a global leader in optical technology, HOYA Vision Care provides innovative vision care solutions for every stage of a patient's life. A steadfast partner to Eye Care Professionals around the world, it stands at the forefront of optical excellence. With a global presence consisting of 43 laboratories and a growing team of 20,000 employees, HOYA Vision Care delivers innovative lenses and other vision care solutions to millions of people in 110 countries.
Every child deserves to have better treatment for their vision health. MiYOSMART is available in more than 30 countries worldwide and over 2 million parents across the world have already trusted the solution for their children.
We focus on a better tomorrow, today. HOYA Vision Care is a place where you can capitalise on your strengths and build a career that aligns with your aspirations. It's a place where you can shape the way you work, guided by our CLEAR Values and empowered by generations of expertise. You can help give the gift of sight to people worldwide. You can give back to the community by being involved in sustainability initiatives and choosing to become a One Vision ambassador. You can be part of our amazing story.
Company career website: Careers | HOYA Vision Care
Follow us @ https://www.linkedin.com/company/hoya-vision-care/
The Position
- Strategies aligned with global/regional regulatory requirements and country businesses.
- Monitor operational progression of pre-marketing authorization activities at cluster level through contact with cluster regulatory agencies or committees, as required.
- Ensures all documents submitted to regulatory agencies are completed and well organized, in regulatory compliance, and presented in a manner that facilitates agency review.
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 degreeor 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 solidexecution and compliance.
- Expertise in the development of strategic regulatory affairs plans
- A track record of successful executionof 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
Flexible Work Arrangements: As this position involves a multi-regional scope, you will be required to participate in meetings and conference calls outside your regular work hours as required.
