Regulatory Affairs Engineer – TECHLINE

LINAK Scandinavia AB; Guderup; On-site; DKK 600,000 - 860,000; Full time

Job summary

LINAK TECHLINE is seeking a Regulatory Affairs Engineer to ensure compliance across the product portfolio. You will work with R&D, test engineers, product managers, and authorities to secure conformance for industrial actuator solutions.

You will advise on regulatory requirements, support labeling, and coordinate certifications while monitoring evolving legislation to maintain market access across global markets. Strong analytical and communication skills are required.

Qualifications

• Experience in Regulatory Affairs.
• Technical background as an electrical or mechanical engineer.
• Interest in product safety, legislation, and technical standards.
• Knowledge of machinery, industrial products, or electromechanical systems.
• May have years of experience in functional safety in industrial and off highway applications.
• Strong analytical and communication skills.
• Ability to work independently while collaborating across functions.
• Speak and write English fluently.

Responsibilities

• Advise project teams on regulatory and compliance requirements.
• Ensure required technical documentation is completed prior to product release and Declaration of Conformity.
• Support product labeling and marking requirements.
• Monitor changes in legislation, standards, and regulatory requirements in relevant markets.
• Coordinate external testing, approvals, and certifications.
• Participate in compliance and risk assessment activities.
• Responsible for product audit internal and external.
• Maintain knowledge of TECHLINE products and applications.

Skills

Regulatory affairs

Engineering background

English proficiency

Analytical skills

Cross-functional work

Job description

Would you like to become a regulatory specialist in an international technology company?

At LINAK TECHLINE®, we develop actuator solutions for a wide range of industrial applications. Due to increasing activity and several new development projects, we are looking for a Regulatory Affairs Engineer to help ensure compliance across our product portfolio.

As a Regulatory Affairs Engineer, you will support development projects with regulatory compliance and product safety requirements. You will work closely with R&D colleagues, test engineers, product managers, certification bodies, and authorities to ensure that our products meet relevant legislative and market requirements. Inspired by the original role's focus on acting as the link between LINAK and regulatory authorities.

Primary tasks

• Advise project teams on regulatory and compliance requirements
• Ensure required technical documentation is completed prior to product release and Declaration of Conformity
• Support product labeling and marking requirements
• Monitor changes in legislation, standards, and regulatory requirements in relevant markets
• Coordinate external testing, approvals, and certifications
• Participate in compliance and risk assessment activities
• Responsible for product audit internal and external
• Maintain knowledge of TECHLINE products and applications
  

Relevant legislation and standards

Depending on product and market, you will work with requirements such as:

• Machinery Regulation
• Low Voltage Directive (LVD)
• Electromagnetic Compatibility Directive (EMC)
• CRA regulation
• ATEX Directive
• RoHS and REACH
• ISO 13849
• ISO 12100
• UL and CSA requirements for North America
• MIL-STD (461 and 810)

You

• have experience with Regulatory Affairs
• have a technical background as an electronical or mechanical engineer
• have an interest in product safety, legislation, and technical standards
• have knowledge of machinery, industrial products, or electromechanical systems
• may have years of experience in functional safety in industrial and off highway applications
• have strong analytical and communication skills
• can work independently while collaborating across functions
• speak and write English fluently

We offer more than just a job

We offer a unique opportunity to become part of a business area with great opportunities to influence both solutions and ways of working. You will have a varied role where you can make a real impact while supporting the continued development of TECHLINE® and help ensure that our products meet regulatory requirements across global markets.

You will join a company that values a healthy work-life balance and where collaboration, flexibility, and knowledge sharing are an integral part of the culture. You will be surrounded by experienced and highly skilled colleagues in an international environment, with plenty of opportunities for both professional and personal development.

For further information about the position, please contact Claus H. Sørensen phone [phone], whom you will report directly to.

We evaluate applications on an ongoing basis and will close the position once the right candidate has been found. Any application deadlines shown are system-generated and not set by LINAK.