d) at Stryker

Selzach, Solothurn, Switzerland

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related field
Minimum 6 years of regulatory affairs experience in medical devices or another highly regulated industry
Strong knowledge of global regulatory pathways, submission requirements, and product lifecycle management
Experience developing regulatory strategies and interacting with regulatory authorities
Ability to analyze complex information, exercise sound judgment, and propose actionable solutions
Strong communication, collaboration, and stakeholder-influencing skills
Ability to manage multiple priorities and operate independently with sound decision-making
Preferred
Master’s degree in Regulatory Science or related field
Regulatory Affairs Certification (RAC)
Experience supporting premarket submissions, post-market activities, and global registrations
Familiarity with clinical investigations, pre-approval inspections, and postmarketing surveillance

Responsibilities

Develop and evolve regulatory strategies by assessing regulatory intelligence, emerging trends, and changes in global requirements
Advise R&D, Quality, Clinical, and Marketing teams throughout the product lifecycle to ensure regulatory compliance, appropriate product claims, and strong submission readiness
Evaluate product concepts, classifications, and regulatory pathways to identify opportunities, risks, and solutions for timely market access
Negotiate with regulatory authorities and lead interactions throughout product development, submission, and review
Prepare, submit, and track global regulatory submissions in alignment with regulatory guidelines and internal quality standards
Assess the impact of proposed clinical, manufacturing, or product changes and recommend regulatory filing strategies
Support the development and implementation of new or updated SOPs, processes, and guidance documents to ensure compliance
Train and mentor stakeholders on regulatory requirements, expectations, and best practices to enhance organizational capability

Skills

Key technologies and capabilities for this role

Regulatory AffairsMedical DevicesGlobal Regulatory PathwaysRegulatory StrategyProduct Lifecycle ManagementRegulatory SubmissionsSOP DevelopmentRegulatory IntelligenceRegulatory ComplianceMarket Access

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

What work flexibility options are available?

The role offers hybrid or onsite work flexibility.

What are the required qualifications for this role?

Candidates need a Bachelor’s degree in Engineering, Life Sciences, or a related field, minimum 6 years of regulatory affairs experience in medical devices or another highly regulated industry, strong knowledge of global regulatory pathways, experience developing strategies and interacting with authorities, plus strong analytical, communication, and prioritization skills.

What is the duration of this position?

The position is initially limited for 12 months with a possibility of an extension.

Does the company emphasize diversity in hiring?

Yes, diversity is important, and they welcome applications from people regardless of ethnic, national or social origin, gender, disability, age or sexual identity.

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