Compliance Engineer at Stryker

Lund, Skane County, Sweden

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related technical field (or equivalent combination of education and experience)
At least 4 years of experience in regulatory compliance, quality assurance, or product development within the medical device industry
Strong understanding of medical device regulations and standards, including EU MDR, FDA 21 CFR Part 820, ISO 13485, and relevant product standards such as IEC 60601 (preferred)
Experience with cybersecurity and/or wireless communication in medical devices, including familiarity with relevant standards and regulatory expectations (preferred)
Experience coordinating internal and external product testing, including working with test houses and certification bodies (preferred)
Familiarity with global regulatory submissions and technical documentation, such as CE marking and declarations of conformity (preferred)
Able to assess compliance issues and implement effective solutions (preferred)
Demonstrated experience working independently while collaborating effectively with cross-functional and global teams (preferred)
Strong analytical skills with the ability to solve process and system-related issues in a regulated environment (preferred)
Proficient in Swedish and English, with excellent verbal and written communication skills (preferred)
Skilled in MS Office and experienced in managing compliance documentation and records (preferred)

Responsibilities

Lead the maintenance and continuous improvement of the quality system to ensure robust, compliant processes that support product regulatory compliance—particularly with medical device regulations such as EU MDR, FDA 21 CFR Part 820, ISO 13485, and applicable product standards
Lead proactive compliance initiatives by monitoring evolving global regulations, standards, and guidance documents (e.g., IEC 60601), assessing their impact on product compliance, and ensuring timely communication and integration across teams and product lines
Identify, develop, and integrate compliance requirements into the product development lifecycle, including new product development and sustaining engineering, to ensure designs meet regulatory expectations and standards
Coordinate and manage product testing activities with external test houses, including planning, documentation, and follow-up on results and corrective actions
Provide regulatory and compliance guidance throughout the product lifecycle—from concept and development to manufacturing, marketing, and post-market changes
Manage compliance-related documentation, including product certifications, and supporting materials required for audits, submissions, and ongoing regulatory alignment
Train, mentor, and support internal teams in understanding and applying medical device compliance requirements and best practices
Collaborate with internal and external stakeholders to support product compliance, certification efforts, and regulatory strategy alignment
Collaborate with cross-functional product development teams to integrate regulatory and compliance requirements into the design and development process, ensuring alignment with project goals, timelines, and applicable medical device regulations

Skills

Key technologies and capabilities for this role

EU MDRFDA 21 CFR Part 820ISO 13485IEC 60601Quality SystemRegulatory ComplianceProduct Development LifecycleProduct TestingAuditsRegulatory SubmissionsMedical Device Regulations

Questions & Answers

Common questions about this position

What is the work arrangement for this Compliance Engineer role?

The position offers hybrid work flexibility and is based in Lund due to team expansion.

What are the minimum education and experience requirements?

A Bachelor’s degree in Engineering, Life Sciences, or a related technical field (or equivalent) and at least 4 years of experience in regulatory compliance, quality assurance, or product development within the medical device industry are required.

What key regulations and standards should candidates be familiar with?

Candidates need a strong understanding of EU MDR, FDA 21 CFR Part 820, ISO 13485, and product standards like IEC 60601.

What does the role involve in terms of team collaboration?

The role includes training and mentoring internal teams, collaborating with cross-functional product development teams, and working with internal and external stakeholders to ensure compliance.

What experience makes a candidate stand out for this position?

Preferred experience includes cybersecurity and/or wireless communication in medical devices, coordinating product testing with test houses and certification bodies, and familiarity with global regulatory submissions.

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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