Head of Regulatory Affairs for RA Project Management
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Smørum
Head of Regulatory Affairs for RA Project Management
Do you have broad knowledge in the field of regulatory affairs? Are you ready to have people management responsibility? Do you see collaboration as being one of the most important aspects for you? And do you want to join a global company with the purpose of delivering life changing hearing healthcare that increases the quality of people’s lives?
If your answer to the questions above is “yes” you might be our new Head of RA Project Management.
The job – Manager for 6 highly professional Regulatory Affairs Managers
As Head of RA Project Management, you will be a part of a RA department of 20 people in total. 13 placed in Denmark and seven placed in Stettin, Poland. The RA department is responsible for the different type of regulatory documentation related to the products, e.g. Safety & EMC approvals, the risk management documentation, the medical device file, and documents used for registration in countries worldwide. The RA Project Management team is a part of the RA department.
The members of the RA Project Management team participate in the developing projects. Here they support the project by (1) writing some of the regulatory documentation, (2) ensures that the product is in compliance with the regulation, and (3) handle the relevant stakeholders to ensure timely deliverables.
The job will consist of several different type of tasks e.g.:
• Managerial responsibility for six RA Project Managers, including people management and delegating of tasks e.g.
• Participation in the development projects as RA Project Manager
• Cooperation with the team in Poland and the homologation team
• Being responsible for RA processes
• Representation of the RA department in different small optimization projects
• Performing training in RA processes
Demant – an organization with the purpose of delivering life changing hearing healthcare
By joining the Demant team, you help bring sounds to the millions of hearing impaired all over the world that enables them to live natural lives with friends and family.
Demant strives to be the leader in high performance hearing solutions and to supply the most sophisticated technology and audiology possible. We have a relentless drive for innovation and is in the absolute forefront of technology, which improves the lives of people with hearing loss.
Demant is certified after ISO 13485:2016 and MDSAP and we have a continually focus on being in compliance also with the local requirements.
The workplace for this position is at Kongebakken, Smørum in Demark. We are around 17.000 people worldwide, and you will be cooperating with people from several places around the world.
You will find the perfect framework for your professional and personal development in a culture built on trust, openness and mutual respect. We welcome you in a growing international company where we push hard to be at the forefront of what is technically possible.
Could we be a match?
It´s important that you have 1- 3 years of professional experience in the RA area and you are a University Graduate (M.Sc. E or similar). We prefer that you have experience from managing a team but is not a necessity.
The ideal candidate has professional knowledge from a regulated industry where auditing, and regulatory documentation are a part of a normal workday. If you have knowledge and experience with ISO 13485, FDA, MDSAP, MDD, MDR (EU), JGMP and other relevant regulatory requirements, we would love to hear from you.
As a person you find it easy to keep the overview while still have focus on the detail, in order to make sure that the task is completed correctly.
Want to join us?
Please send your CV and application as soon as possible, as we are screening applications continuously. The application deadline is February 7, 2021.
Please notice we will only consider candidates using the electronic recruitment system.
If you want more information about the position, please contact Mette B. Dyhrberg at +45 20 63 01 83.
We look forward to hearing from you.
About Demant
Demant is a world-leading hearing healthcare group that offers solutions and services to help people with hearing loss connect and communicate with the world around them. For more than a century, the Demant Group has played a vital part in developing innovative technologies and know-how to help improve people’s hearing and health. In every aspect, from hearing devices, hearing implants and diagnostic equipment to hearing care all over the world, Demant is active and engaged. A growing business in intelligent audio solutions for gaming and office communication is also a significant part of the Group.
The Demant Group operates in a global market with companies in more than 30 countries, employs more than 15,000 staff and generates annual revenue of DKK 15 billion. Our products are sold in more than 130 countries where we create life-changing differences through hearing health.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Smørum.
Jobbet er oprettet på vores service den 7.1.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Afdelingsleder
- Smørum
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