Senior Director, Regulatory Affairs at Stryker

San Jose, California, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

BS in Engineering or other relevant field of study
Minimum of 10 years’ experience
Master's Degree or equivalent preferred
RAC desired
Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements
Demonstrated expertise in regulatory systems in a regulated environment
Demonstrated ability to manage complex projects
Demonstrated verbal, written, and interpersonal communication skills
Demonstrated ability to work in a team environment, interact effectively with management from other functions
Demonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory, and compliance targets
Demonstrated ability to initiate work
Demonstrated analytical ability
Demonstrated ability to make effective decisions
Experience with recruiting, people development
Based in San Jose, CA with a hybrid work schedule of three days per week in office (relocation support provided)
Willingness to travel 20%

Responsibilities

Ensure divisional achievement of quality, regulatory, and compliance targets
Direct activities to ensure new product development and product sustainment meet regulatory requirements
Develop, lead, and execute a regulatory strategy ensuring that it is appropriate and effective in meeting the business needs
Responsible for the selection, supervision, development and objective-setting for team members
Develop best practices to ensure compliance and drive revenue through improved customer experience
Provide a platform for process improvement
May serve as alternate Management Representative
Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets
Recruit, select, and on-board top talent
Develop talent within team to increase performance
Actively address performance issues on team
Maintain a high level of team engagement
Leads advocacy activities of a more advanced and global strategic nature

Skills

Key technologies and capabilities for this role

Regulatory AffairsFDAISOInternational RegulationsRegulatory StrategyProduct DevelopmentComplianceQuality AssuranceTeam LeadershipRAC

Questions & Answers

Common questions about this position

What is the salary range for the Senior Director, Regulatory Affairs position?

The salary range is $223,000 - $379,000 plus bonus eligible, generally eligible for short-term and long-term financial incentives, and benefits. Individual pay is based on skills, experience, and other relevant factors.

What is the work arrangement and location for this role?

The role is hybrid with three days per week in office and requires being based in San Jose, CA. Relocation support can be provided.

What education and experience are required for this position?

A BS in Engineering or other relevant field is required, with a minimum of 10 years’ experience. A Master's Degree or equivalent and RAC are preferred.

What key skills and competencies are needed for this role?

Demonstrated knowledge of regulatory requirements including ISO, FDA, and International; expertise in regulatory systems; ability to manage complex projects, teams, and communicate effectively are required.

What leadership responsibilities does this role involve?

The role includes selecting, supervising, developing, and setting objectives for team members, recruiting top talent, addressing performance issues, and maintaining high team engagement.

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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