Compliance Engineer

Stryker Group; Lunds kommun; On-site; SEK 800 000 - 1 000 000; Full time

Job summary

A global leader in medical technologies is seeking a Compliance Engineer in Lund to ensure compliance with medical device regulations. You will lead quality system improvements, guide product compliance, and collaborate with teams. The ideal candidate has a Bachelor's degree in a relevant field and 4+ years of experience in regulatory compliance within the medical device industry. Proficiency in Swedish and English is required.

Qualifications

• 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.

Responsibilities

• Lead the maintenance and improvement of quality systems for regulatory compliance.
• Implement compliance initiatives based on evolving regulations.
• Develop compliance requirements for product development.
• Manage product testing activities with external houses.
• Provide regulatory guidance throughout the product lifecycle.

Skills

Regulatory compliance

Quality assurance

Analytical skills

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in Engineering, Life Sciences, or related

Tools

MS Office

Job description

Overview

Due to expansion in Lund, Stryker is recruiting for a Compliance Engineer to add the team. In this role, you will act as a bridge between the technical aspects of medical device development and the regulatory landscape, ensuring that devices are safe, effective, and compliant with all applicable requirement, customer expectations, and our company’s compliance goals.

Key Areas of Responsibility

• Lead the maintenance and continuous improvement of the quality systemto 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 teamsin understanding and applying medical device compliance requirements and best practices.
• Collaborate with internal and external stakeholdersto 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.

Minimum 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.

Preferred Requirements

• 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.
• Experience with cybersecurity and/or wireless communication in medical devices, including familiarity with relevant standards and regulatory expectations.
• Experience coordinating internal and external product testing, including working with test houses and certification bodies.
• Familiarity with global regulatory submissions and technical documentation, such as CE marking and declarations of conformity.
• Able to assess compliance issues and implement effective solutions.
• Demonstrated experience working independently while collaborating effectively with cross-functional and global teams.
• Strong analytical skills with the ability to solve process and system-related issues in a regulated environment.
• Proficient in Swedish and English, with excellent verbal and written communication skills.
• Skilled in MS Office and experienced in managing compliance documentation and records.

The Company

Jolife AB, a wholly owned company by Stryker Inc, develops and markets the LUCAS ™ Chest Compression System, with related accessories for the global market. LUCAS ™ is a Swedish breakthrough innovation for mechanical chest compressions used during cardiopulmonary resuscitation (CPR).

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.