Regulatory Affairs Specialist

Phillips Medisize; Struer; On-site; DKK 480,000 - 720,000; Full time

Job summary

Phillips Medisize seeks a Regulatory Affairs professional to manage global device registrations and regulatory submissions from the Struer and Virum centers. You will work with engineers and project managers to meet country-specific requirements and maintain approval status for evolving products.

The role requires a life science or engineering degree, medical device regulatory experience, 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.
• Willingness and ability to quickly acquire new knowledge.
• Systematic, rigorous, and structured thinking and documentation.
• Strong organizational skills and 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.

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

English communication

Organizational skills

Education

Bachelor’s degree in life science, engineering or equivalent

Tools

MS Office

Job description

Struer, North Denmark Region | Virum, Capital Region of Denmark

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.

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

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 ourbusiness 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.