Associate Manager, Regulatory Affairs & Market Access at Stryker

Seoul, South Korea, South Korea

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

BA/BS in Engineering, Science, medical or related field
Over 10 years of experience in RA/MA preferred
Master's Degree or equivalent desired
Good command of English (must)
Relevant experience dealing with external parties such as government 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 interpret in regulation/policy perspectives

Responsibilities

Manage pre-market regulatory processes for Neurovascular business unit, including new product registrations, maintenance, KGMP certifications, and regulatory compliance activities in compliance with regulatory requirements and Stryker policy
Ensure overall management of HIRA reimbursement pricing process including HTA evaluation if required
Collaborate with commercial, RAQA team and division team to achieve performance objectives
Ensure regulatory issues are appropriately evaluated
Manage 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 country regulatory processes to Neurovascular division
Comply with regulations and Stryker policy and act as a key auditee for assigned responsibility
Develop market access strategy and related medical procedure fee to align with business needs
Manage reimbursement pricing strategy and supervise whole registration process to achieve higher reimbursement pricing for business competitiveness
Conduct HTA review for new technology in collaboration with HCP to create medical procedure related and business opportunity
Perform post-market management of reimbursement price like re-evaluation, price investigation, etc. to defend against price cut threats by government
Responsible for annual planning of submission/registration/reimbursement pricing, and management KPI metrics
Collaborate with RAQA, Design division, APAC & Corp RAQA to ensure performance objectives, RAQA regulatory metrics and project success
Build relationships & educate Commercial with relevant functions by providing RAMA induction training
Build good relationship and reputation of Stryker to relevant health authorities and advocate Stryker

Skills

Key technologies and capabilities for this role

Regulatory AffairsPre-Market RegistrationsKGMP CertificationsRegulatory ComplianceHIRA ReimbursementHTA EvaluationMarket Access StrategyReimbursement PricingRAQA CollaborationNeurovascular RegulationsPost-Market ManagementKPI Metrics

Questions & Answers

Common questions about this position

What is the work arrangement for this position?

The position offers a hybrid work flexibility.

What salary or compensation is offered for this role?

This information is not specified in the job description.

What qualifications and experience are required for this role?

Candidates need a BA/BS in Engineering, Science, medical or related field, over 10 years of experience in RA/MA preferred, and a Master's Degree or equivalent desired. Good command of English is required, along with relevant experience dealing with external parties such as government officials.

What key skills are needed to succeed in this role?

Key skills include demonstrated knowledge of regulatory requirements, ability to prioritize and manage multiple projects, process improvement management, trending and analysis reporting, and professional communication skills.

What makes a strong candidate for this Associate Manager position?

Strong candidates will have over 10 years of RA/MA experience, advanced degrees, English proficiency, experience with government officials, and skills in regulatory compliance, project management, and cross-functional collaboration.

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

Land your dream remote job 3x faster with AI

Try Jobo Free