Regulatory Affairs & Market Access Manager

This role is to manage the pre-market regulatory processes for the assigned business unit, including new product registrations, maintenance, KGMP certifications and regulatory compliance activities in compliance with regulatory requirements and Stryker policy. This role is also to ensure overall management of HIRA reimbursement pricing process including HTA evaluation if required. Additionally it collaborates with commercial, RAQA team and division team to achieve performance objectives.

Critical success factors / key deliverables:

• Accountable for the pre-market regulatory processes for Neurovascular business such as new product registrations, maintenance, KGMP certificaitons, and relevant regulatory compliance activities.
• Manage it to ensure regulatory issues are appropriately evaluated
• Properly manage the necessary actions for coming regulation/policy changes by providing guidances and implement plans for adherence to new regulatory requirements or expectations
• Serve as Subject Matter Expert for the coutnry regulatory processes to Neurovascular division
• Comply with the regulation and Stryker policy and act as a key auditee for the assigned responsibility
• Develop market access strategy and related medical procedure fee to align with business needs.
• Manage reimbursement pricing strategy and supervising whole registration process. In order to have business success, higher reimbursement pricing to be considered to have business competitiveness.
• nHTA review for the new technology in collaboration with HCP to create medical procedure related and business opportunity
• Post market management of reimbursement price like re-evaluation, price investigation, etc. to defense price cut threatening by government
• Responsible for the annual planning of submission/registration/reimbursement pricing, and management KPI matrics
• Collaborate with RAQA, Design division, APAC & Corp RAQAC to ensure performing objectives, RAQA regulatory metrics and to make project in success
• Build relationships & educate Commercial with relevant functions by providing RAMA induction training.
• Build good relationship and reputation of Stryker to the relevant health authorities and advocate Stryker

Knowledge / Skills / Attributes

Academic qualifications / degree & relevant prior experience:

Key strengths / personal attributes for the role:

• +BA/BS in Engineering, Science, medical or related
• Over 10 years experiences in RA/MA preferred
• Master’s Degree or equivalent desired.
• Good command in English(must)
• Relevant experience dealing with external parties such as governments officials
• Demonstrated knowledge and application of regulatory requirements
• Demonstrated ability to effectively prioritize, manage multiple project workloads and process improvement management skills
• Demonstrated experience with trending and analysis reporting
• Professional communication skills
• Influence across the organization either commercial and functional team
• Ability to understand scientific and health economics concepts and interpreate in regulation /policy perspectives