Lead Specialist, Safety Vigilance at Stryker

Tokyo, Japan

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

BS in Engineering, Science, or related degree; or MS in Regulatory Science
Typically a minimum of 4 years' experience
MS or RAC(s) preferred
Strong project management, writing, coordination, and execution of regulatory items
Emphasis on technical and scientific regulatory activities
Knowledge and skills in regulatory pathways, risk-benefit analysis, communication and collaboration internally and externally, submission, registration, obtaining approval, documentation, compliance, post-marketing surveillance/vigilance and distribution
Ability to work under general supervision, plan, conduct and supervise assignments
Ability to review progress, evaluate results, recommend changes in procedures
Operates with appreciable latitude for unreviewed action or decision
Ability to review progress with management and may direct work of Specialist or Sr. Specialist
Seeks out diverse ideas, opinions, and insights and applies them in the workplace
Connects and relates well with people who think and act differently
Embraces scrutiny and accepts feedback as opportunity to learn and improve
Chooses the best alternative to achieve desired outcome or effect, considering risks, tradeoffs, timing, and available resources
Navigates the dynamics, alliances, and competing requirements

Responsibilities

Develops and implements processes involved with maintaining annual licenses, registrations, and listings
Reviews and approves advertising and promotion to ensure regulatory compliance
Assures post-market regulatory requirements are met (e.g. required reports, supplemental submissions and other post-marketing commitments)
Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge
Participates in implementation of regulatory strategy and processes for handling recalls and communication to stakeholders (e.g. HCP, patient, distributor, and health authorities)
Reports product safety issues to regulatory authorities as required, to comply with local, regional, and global regulations
Provides required information in support of product reimbursement requests
Provides regulatory input and appropriate follow-up for inspections and audits
Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
Evaluates proposed products for regulatory classification and jurisdiction
Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
Negotiates with regulatory authorities throughout the product lifecycle
Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
Assists other departments in the development of SOPs to ensure regulatory compliance

Skills

Key technologies and capabilities for this role

Regulatory CompliancePost-Market SurveillanceSafety VigilanceRegulatory SubmissionsRecall ManagementAuditsInspectionsRegulatory StrategyMarket AccessProduct ReimbursementRegulatory Intelligence

Questions & Answers

Common questions about this position

What is the salary for the Lead Specialist, Safety Vigilance position?

This information is not specified in the job description.

Is this role remote, hybrid, or onsite?

The position offers hybrid or onsite work flexibility.

What education and experience are required for this role?

A BS in Engineering, Science, or related degree is required, or an MS in Regulatory Science; typically a minimum of 4 years' experience. An MS or RAC(s) is preferred.

What key skills and competencies are needed for this position?

Strong project management, writing, coordination, and execution of regulatory items are required, with emphasis on technical and scientific regulatory knowledge.

What makes a strong candidate for this Lead Specialist role?

Candidates with an MS or RAC(s), at least 4 years of regulatory experience, and strong project management, writing, and technical regulatory skills will stand out.

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.

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