Regulatory Affair Specialist
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Smørum
Make a dream come true within regulatory affairs - homologation
Oticon is part of . We develop, produce and sell cutting-edge, high-quality hearing aids worldwide.
Then this job might be the one you are looking for.
The job as Regulatory Affair Specialist with focus on homologation
Our overall aim is to get our products as fast as possible to our customers in the 80 different markets we are represented in. For that to happen, the customers need to have the right certifications and approvals in place.
We constantly launch new products for the brands Oticon, Bernafon, Sonic and Philips, and the regulatory landscape is constantly changing. We need you to be on the top of that.
Some of our tasks will be:
Your job is located at our headquarter in Smørum. Working from home is indeed possible pending tasks and meetings.
Part of Regulatory Affairs and International Sales
Professionally you will belong to Regulatory Affairs team with five colleagues, who have the responsibility for homologation for Wholesales.
You will report to Pernille Parsberg Skydsgaard, Senior Manager, Homologation and Clinical Affairs, Regulatory Affairs, who, as you, are in Smørum.
Pernille has been with for 10 years. Pernille as well as the rest of her experienced team will be of a big help for you to land well in this job. The atmosphere is approachable, open and welcoming, encouraging discussion and the exchange of knowledge at its core.
Your everyday life will take place in International Sales, lead by Jakob Brøgger Kjærgaard, General Manager, Hearing Aid Export.
Jakob’s team consists of 20 colleagues stretching from salespeople to audiological trainers over project managers, back-office people and business developers. Things don't stand still here and there is a short distance from idea to decision to execution.
How we land you well in this job
You are replacing a treasured colleague, who has been with us for a lifetime and is now retiring. We will ensure adequate time for hand-over, so valuable experience is not lost.
The job will not be transferred 1:1 as some of the existing tasks will be transferred to a colleague in Poland.
Our expectations to you
You have a BSc. in administration or equivalent relevant area.
Too that you come either with 1-2 years of experience within regulatory affairs from an identical position or with 5-6 years of experience from a position where you have worked with registration, export procedures, implementation of legal requirements or alike where our position will be an obvious next career step.
In your job you are used to:
How to apply
In we trust and value professionalism, experience, involvement and we acknowledge that employees have a life outside as well.
If this is what you are looking for, then send your application and CV no later than the 13th of October 2025.
We expect the 1st interviews: 21st and 22nd of October and the 2nd interviews: 29th and 30th of October.
If you have any questions regarding the position, please contact Pernille Parsberg Skydsgaard, Senior Manager, Homologation and Clinical Affairs, Regulatory Affairs at psky@.com.
Please note that we do not accept applications from external recruiters, and we only accept applications via our recruitment systems.
We look forward to hearing from you.
At we value diversity, equity, and inclusion (DE&I) and we are committed to creating an inclusive working environment. We welcome applications from alle 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 supports United Nations Sustainable Development Goal 5 on gender equality. #LI-HYBRID #LI-BS1
Oticon is part of . We develop, produce and sell cutting-edge, high-quality hearing aids worldwide.
- Would you like to participate in improving the quality of life for people with hearing loss all over the world?
- And would you like a job where you focus on ensuring compliance and a smooth market entry?
Then this job might be the one you are looking for.
The job as Regulatory Affair Specialist with focus on homologation
Our overall aim is to get our products as fast as possible to our customers in the 80 different markets we are represented in. For that to happen, the customers need to have the right certifications and approvals in place.
We constantly launch new products for the brands Oticon, Bernafon, Sonic and Philips, and the regulatory landscape is constantly changing. We need you to be on the top of that.
Some of our tasks will be:
- Regulatory Compliance: Research and interpret regulatory requirements specific to hearing aids for various markets to ensure compliance with local and international standards.
- Documentation: Prepare and submit accurate and timely documentation to regulatory authorities in all markets.
- Apply for free sales certificates.
- Work closely with distributors to understand market-specific requirements and support their efforts in attaining compliance.In this role you will be working with stakeholders all over the organization, from customer service to production, quality, legal to finance.
Your job is located at our headquarter in Smørum. Working from home is indeed possible pending tasks and meetings.
Part of Regulatory Affairs and International Sales
Professionally you will belong to Regulatory Affairs team with five colleagues, who have the responsibility for homologation for Wholesales.
You will report to Pernille Parsberg Skydsgaard, Senior Manager, Homologation and Clinical Affairs, Regulatory Affairs, who, as you, are in Smørum.
Pernille has been with for 10 years. Pernille as well as the rest of her experienced team will be of a big help for you to land well in this job. The atmosphere is approachable, open and welcoming, encouraging discussion and the exchange of knowledge at its core.
Your everyday life will take place in International Sales, lead by Jakob Brøgger Kjærgaard, General Manager, Hearing Aid Export.
Jakob’s team consists of 20 colleagues stretching from salespeople to audiological trainers over project managers, back-office people and business developers. Things don't stand still here and there is a short distance from idea to decision to execution.
How we land you well in this job
You are replacing a treasured colleague, who has been with us for a lifetime and is now retiring. We will ensure adequate time for hand-over, so valuable experience is not lost.
The job will not be transferred 1:1 as some of the existing tasks will be transferred to a colleague in Poland.
Our expectations to you
You have a BSc. in administration or equivalent relevant area.
Too that you come either with 1-2 years of experience within regulatory affairs from an identical position or with 5-6 years of experience from a position where you have worked with registration, export procedures, implementation of legal requirements or alike where our position will be an obvious next career step.
In your job you are used to:
- Understand stakeholder and business demands with a positive and constructive problem-solving mindset.
- Work systematically and structured managing several tasks in parallel.
- Work confidently in your coordination and planning.
- Work detail-oriented with a focus on being compliant.
- Get things done.
- Work in English – written and oral.
- Network with other departments.
- Talk about other things than just work.
How to apply
In we trust and value professionalism, experience, involvement and we acknowledge that employees have a life outside as well.
If this is what you are looking for, then send your application and CV no later than the 13th of October 2025.
We expect the 1st interviews: 21st and 22nd of October and the 2nd interviews: 29th and 30th of October.
If you have any questions regarding the position, please contact Pernille Parsberg Skydsgaard, Senior Manager, Homologation and Clinical Affairs, Regulatory Affairs at psky@.com.
Please note that we do not accept applications from external recruiters, and we only accept applications via our recruitment systems.
We look forward to hearing from you.
At we value diversity, equity, and inclusion (DE&I) and we are committed to creating an inclusive working environment. We welcome applications from alle 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 supports United Nations Sustainable Development Goal 5 on gender equality. #LI-HYBRID #LI-BS1
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Smørum.
Jobbet er oprettet på vores service den 10.9.2025, 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.
- Øvrige
- Smørum
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