Manager, Regulatory Affairs APAC

About HOYA Surgical Optics (HSO)
HOYA Surgical Optics (HSO) is the globally leading Preloaded Intraocular Lens (IOL) focused company that provides technologies and solutions that exceed expectations, enabling ophthalmic surgeons to focus on restoring sight. We are dedicated to improving the vision and quality of life for millions of people suffering from cataract, and helping them celebrate life visually.
At HSO, People is the key factor to our success. We aim to create a conducive work environment for our employees around the globe, and to promote an inclusive culture based on our core values – Excellence, Passion, Innovative, Collaboration, and Accountability.

HSO way of working
In fulfilling our roles, we are
•    Accountable for our own capabilities and development.
•    Focused on delivering results without excuses, and
•    Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.

We are looking for people who
•    See beyond self and are impact focused.
•    Consider the needs, challenges, and objectives of every person they interact with.
•    Exhibit positive reinforcement to help others succeed.

About the role
Job Title: Manager, Regulatory Affairs APAC
Works closely with and have impact on: Commercial, Consultants, Distributors, QA, CTM, Marketing, RA
Reports to: Director, Regulatory Affairs APAC
Function: Regulatory Affairs
Work Location/Site: GHQ

Role Overview
Efficiently obtaining and maintaining product registrations in APAC countries (exclude China and Japan) by working closely with distributors, consultants, regulators, HOYA affiliates. Representing RA at meetings such as life cycle management, product development, etc.

Duties and Responsibilities
•    Participate in projects and provide APAC regulatory strategy and timelines where required
•    Ensure regulatory submissions are executed on-time and in a cost-effective manner
•    Maintain regulatory licenses and on-time renewals to avoid supply disruption
•    Adequate and effective relationshlp management with Third Party License Holders, Regulatory Agencies, Consultants, stakeholders to meet the regulatory goals
•    Ensure regulatory activities performed are in compliance with both internal and external regulations/requirements
•    Support the business in obtaining timely regulatory documentation required to import/export and/or to obtain reimbursement/tender approval
•    Perform timely and correct regulatory impact assessment and subsequent submissions are filed accordingly with minimal business impact
•    Prompt review and approval of promotional and marketing materials, ensure regulatory compliance with internal and external requirements
•    Monitor changes in local standards, regulations, guidance documents etc. and inform the relevant stakeholders about the associated impact (where applicable)
•    Provide regulatory expertise within the APAC RA team (e.g. RA Specialists) and to other stakeholders on regulatory issues
•    Oversee Global/APAC registration status and perform regulatory control for product release 
•    Support internal audit and follow up on the actions item (if any)
•    Participate in Post market activities (e.g. AE, FSCA) where required
•    Work closely with CTM on the clinical requirements where necessary

Requirements
Experience
•    Minimum 5 years’ experience in Regulatory Affairs in medical device industry in APAC, especially in Australia, Korea, South Asia in a multi-cultural environment
•    Preferably experienced in Class 3/Class D devices

Skills/Accreditations 
•    Hands-on and in-depth technical experience in dossier preparation, regulatory submissions, queries response in Distributor and Direct markets across APAC
•    Excellent interpersonal and communication skills
•    Initiative and excellent problem solving skills
•    Able to work independently with minimal supervision
•    Meticulous and attention to details
•    Fluent command of English, strong and effective technical writing, documentation and communication across different departments and organizations
•    Knowledge in other Asian languages would be an advantage

Academic Qualifications 
•    Minimally University Degree in Science (Pharmacy, Pharmaceutical Science) or related degree/diploma in Science, Engineering, and/or Biotechnology

Travel requirements 
•    10 - 20% of time in a year