Regulatory Affairs Specialist

Phillips Medisize; Kongens Lyngby; On-site; DKK 420,000 - 660,000; Full time

Job summary

Phillips Medisize is seeking a Regulatory Affairs professional to join our Global Innovation & Development Center in Denmark. You will manage country-specific regulatory requirements, prepare submission documents, and work closely with project managers, engineers, and regulatory teams to obtain market clearances.

The role requires a bachelor’s degree in life science or engineering, experience in medical device regulatory submissions, and strong English communication.

Qualifications

• Bachelor’s degree in life science, engineering or equivalent.
• Working experience in regulatory within the medical device.
• Experience in preparing technical documentation intended to be used for a submission.
• Excellent written and verbal communication skills in English.
• Proficiency with MS Office.

Responsibilities

• Maintain a deep understanding of country-specific regulatory requirements.
• Execute regulatory strategy by generating country-specific regulatory documentation.
• Work in close cooperation with the project managers, engineers, and regulatory team.
• Identify and interface with local representatives worldwide.
• Review and ensure compliance of the technical documentation.
• Assemble regulatory submission packages.
• Submit required documentation to gain market clearance.
• Interact with customers and regulatory authorities to ensure regulatory clearance.
• Support development and improvement of the regulatory affairs & submission process.
• Maintain market clearance and assess change impact on approval status.
• Participate in audits from authorities, customers and notified bodies.

Skills

Regulatory Affairs

MS Office

Organization

Proactive mindset

English communication

Education

Bachelor’s degree in life science, engineering or equivalent

Job description

Your Job

Are you interested in being part of a team responsible for registration of medical devices worldwide? Are you interested in working in a challenging regulatory environment at the interface between device and drug regulations, and willing to expand your regulatory expertise?

Then you may be the person we are looking for to join our growing team in Phillips-Medisize’s Global Innovation & Development Center based in Struer and Virum.

What You Will Do

• Maintain a deep understanding of country-specific regulatory requirements.
• Execute regulatory strategy by generating country-specific regulatory documentation.
• Work in close cooperation with the project managers, engineers, and regulatory team.
• Identify and interface with local representatives worldwide.
• Review and ensure compliance of the technical documentation.
• Assemble regulatory submission packages.
• Submit required documentation to gain market clearance.
• Interact with customers and regulatory authorities to ensure regulatory clearance.
• Support development and improvement of the regulatory affairs & submission process.
• Maintain market clearance and assess change impact on approval status.
• Participate in audits from authorities, customers and notified bodies.

Who You Are (Basic Qualifications)

• Bachelor’s degree in life science, engineering or equivalent.
• Working experience in regulatory within the medical device
• Experience in preparing technical documentation intended to be used for a submission.
• Willingness, and ability to quickly acquire new knowledge.
• Systematic, rigorous, and structured thinking and documentation.
• Strong organizational skills, and the ability for multi-tasking.
• Pro-activity, self-drive and goal oriented.
• Ability to work in an evolving, challenging, and multi-disciplinary environment.
• Excellent written and verbal communication skills in English.
• Proficiency with MS Office.

What Will Put You Ahead

• Experience with worldwide registration of medical devices.
• Experience in medical device approval in one or more of the following Japan, India, China, Eurasian Union, Australia & Gulf Countries and/or Brazil.

Who We Are

Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the world, we share our customers’ mindset that every product is critical to a healthcare provider and their patients somewhere in the world. Molex is a multi-sector global electronics brand owned by Koch, Inc., one of the world’s largest privately held companies. Discover your potential to make a difference.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.