Engaged Regulatory Affairs Specialist for our Regulatory Affairs department
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Are you interested in learning the regulatory requirements towards hearing aids? Do you enjoy participating in many different tasks and use your RA knowledge? 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 Regulatory Affairs Specialist.
An organization with the purpose of delivering life changing technology
Oticon strives to be the leader in high performance hearing solutions and to supply the most sophisticated technology and audiology possible. We have a great desire for innovation and is in the absolute forefront of technology, which improves the lives of people with hearing loss.
Oticon is certified after ISO 13485:2016 and MDSAP and we have continuous focus on being in compliance also with the local requirements.
The team
You will be a part of the Regulatory Affairs (RA) department of 21 colleagues - 13 placed in Denmark and 8 placed in Stettin, Poland. The RA department is responsible for the different types 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.
Our RAP (Regulatory Affairs Project Leader) team is part of the RA department and the members of the RAP team participate in the development projects. Here they support the projects by (1) writing some of the regulatory documentation, (2) ensuring that the product is compliant with the regulation, and (3) cooperate with the relevant stakeholders to ensure timely deliverables.
Head of RAP team, Mette describes the team as: “a good mix of nationalities and great team spirit. We work closely together on projects and value knowledge sharing, also with our colleagues in Poland. I encourage to an open and forthcoming culture that enables good discussions on a daily basis”.
Joining us, you can look forward to the following tasks;
Your impact
By joining the Oticon 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. We are +18.000 people worldwide, and you will be cooperating with colleagues 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 work hard to be at the forefront of what is technically possible.
Could we be a match?
You can be newly graduated within M.Sc. E or similar or having 1- 3 years of experience from a regulated industry and the RA area. Professional knowledge and experience with ISO 13485 & MDD, MDR (EU) would be an advantage, but not a must.
As a person you find it easy to keep the focus on the details while you still have overview of the whole project. You are responsible and deliver high quality work, and the same time make sure that deadlines are met and you thrive working in an agile project organization.
You are fluent in English, written as well as verbally – Danish is an asset, but not a must. Finally, the most important skills are a positive and engaging mindset, natural curiosity on everything that you have not tried before and an openness to learn from your colleagues.
Want to join us?
Please send your CV and application as soon as possible, as we are screening applications continuously. Please notice we will only consider candidates using the electronic recruitment system and application deadline is June 11th, 2023.
If you want more information about the position, please contact Head of RAP team, Mette Leth Schousboe at [email protected].
We are looking forward to hearing from you.
At Demant we value diversity, equity and inclusion (DE&I) and we are committed to creating an inclusive working environment. We welcome applications from all qualified candidates regardless of ethnic background, personality, age, gender, and education. Diversity is part of our cultural DNA. Women in STEM areas are particularly encouraged to apply, as Demant supports United Nations Sustainable Development Goal 5 on gender equality.
If your answer to the questions above is “yes” you might be our new Regulatory Affairs Specialist.
An organization with the purpose of delivering life changing technology
Oticon strives to be the leader in high performance hearing solutions and to supply the most sophisticated technology and audiology possible. We have a great desire for innovation and is in the absolute forefront of technology, which improves the lives of people with hearing loss.
Oticon is certified after ISO 13485:2016 and MDSAP and we have continuous focus on being in compliance also with the local requirements.
The team
You will be a part of the Regulatory Affairs (RA) department of 21 colleagues - 13 placed in Denmark and 8 placed in Stettin, Poland. The RA department is responsible for the different types 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.
Our RAP (Regulatory Affairs Project Leader) team is part of the RA department and the members of the RAP team participate in the development projects. Here they support the projects by (1) writing some of the regulatory documentation, (2) ensuring that the product is compliant with the regulation, and (3) cooperate with the relevant stakeholders to ensure timely deliverables.
Head of RAP team, Mette describes the team as: “a good mix of nationalities and great team spirit. We work closely together on projects and value knowledge sharing, also with our colleagues in Poland. I encourage to an open and forthcoming culture that enables good discussions on a daily basis”.
Joining us, you can look forward to the following tasks;
- Participate in the development projects as RAP to ensure that the right documentation is made
- Cooperation with R&D in the development of products
- Cooperation with the team in Poland and the homologation team
- Alignment with the other RAPs regarding RA processes
- Participate in optimization projects
Your impact
By joining the Oticon 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. We are +18.000 people worldwide, and you will be cooperating with colleagues 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 work hard to be at the forefront of what is technically possible.
Could we be a match?
You can be newly graduated within M.Sc. E or similar or having 1- 3 years of experience from a regulated industry and the RA area. Professional knowledge and experience with ISO 13485 & MDD, MDR (EU) would be an advantage, but not a must.
As a person you find it easy to keep the focus on the details while you still have overview of the whole project. You are responsible and deliver high quality work, and the same time make sure that deadlines are met and you thrive working in an agile project organization.
You are fluent in English, written as well as verbally – Danish is an asset, but not a must. Finally, the most important skills are a positive and engaging mindset, natural curiosity on everything that you have not tried before and an openness to learn from your colleagues.
Want to join us?
Please send your CV and application as soon as possible, as we are screening applications continuously. Please notice we will only consider candidates using the electronic recruitment system and application deadline is June 11th, 2023.
If you want more information about the position, please contact Head of RAP team, Mette Leth Schousboe at [email protected].
We are looking forward to hearing from you.
At Demant we value diversity, equity and inclusion (DE&I) and we are committed to creating an inclusive working environment. We welcome applications from all qualified candidates regardless of ethnic background, personality, age, gender, and education. Diversity is part of our cultural DNA. Women in STEM areas are particularly encouraged to apply, as Demant supports United Nations Sustainable Development Goal 5 on gender equality.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Smørum.
Jobbet er oprettet på vores service den 23.5.2023, 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.
- Apoteker
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