Regulatory Affairs Specialist
Do you want to be part of a team responsible for regulatory approval and registration of combination products in Europe, America, Asia, and Australia?
Are you committed to ensure safe and effective medical development, interested to work in a challenging regulatory environment involving interface with 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 Virum and Struer
What You Will Do In Your Role
- Drive or participate in the development of regulatory strategies.
- Maintain a deep understanding of new and existing regulatory requirements.
- Support the design and development team, and our customers in identifying applicable regulatory requirements, their impact and how to interpret them.
- Execute regulatory strategy by generating necessary regulatory documentation.
- Work in close cooperation with the design and development, risk management, usability engineering, clinical, testing, and manufacturing department.
- Review and ensure compliance of the technical documentation.
- Assemble regulatory submission package and support submission process.
- Interact with customers and regulatory authorities to ensure regulatory clearance.
- Maintain technical documentation to ensure product conformity and clearance.
- Support development and improvement of the regulatory affairs & submission process.
- Assist the company during customer audits, certification audits and inspections.
The Experience You Will Bring
- Bachelor’s degree in life science or engineering.
- Proven experience in quality or regulatory role in the medical device industry.
- Deep understand of the Medical Device Regulation (EU) 2017/745, and medical device development standard ISO 13485
- Experience in preparing technical documentation intended to be use for a submission in Europe, 510(k) submissions, Device Master File (MAF), and foreign registration.
- Willingness, and ability to quickly acquire new knowledge.
- Pragmatic and holistic approach toward regulatory interpretation and implementation.
- Systematic, rigorous, and structured thinking and documentation.
- Strong organizational skills, and the ability for multi-tasking.
- Pro-activity, self-drive and commitment to process improvement.
- Ability to work in an evolving, challenging, and multi-disciplinary environment.
- Excellent written and verbal communication skills in English.
- Ability to travel to our plant in Struer.
What Will Put You Ahead
- Experience with regulatory submission outside Europe and United States.
- Knowledge of medical device development standards ISO 14971, IEC 6230
- Knowledge of technical and injector specific standards, such IEC 60601 and 11608.
What We Offer
- Opportunity to join a growing team working in a fast pace and multidisciplinary environment.
- Collaborate with the regulatory department of leading pharmaceutical companies around the world.
- Mobile Phone
- Broadband connection at home
- Private health insurance
- Competitive pension scheme.
Phillips-Medisize A/S is part of the Pharmaceutical and Medical Division of Molex, a leader in the design, development and delivery of advanced drug delivery devices and connected health solutions.
Phillips-Medisize A/S is collaborating with leading pharmaceutical companies worldwide by offering innovative and integrated solutions supported by an end-to-end service from Strategy to Launch. Read more about Phillips-Medisize A/S at phillipsmedisize.com.