Regulatory Affairs Specialist

Are you looking for new challenges? Would you like to be part of a great team with a broad range of regulatory tasks and a place where we learn as part of our journey? Then [xxxxx] might be your next career move!

[xxxxx] is a small company specializing in the technology of ultra long-term ( 30 days) subcutaneous electroencephalogram (EEG) monitoring contributing to epilepsy management. We are currently on the market in EU, Switzerland and United Kingdom (UK) and have an ongoing clinical investigation (IDE) in the United States.

We are looking for a Regulatory Affairs Specialist to join our Quality Assurance and Regulatory Affairs department. In Regulatory Affairs, our key focus is to ensure compliance with legislation and guidance for medical devices to support our product portfolio and business strategies. We monitor external requirements, evaluate complaints for reportability (vigilance), write post-market surveillance documentation, prepare regulatory device submissions, and communicate with partners and authorities worldwide.

Your main responsibilities will be

- Daily evaluation of customer complaints for reportability

- Vigilance reporting to authorities

- Drive and facilitate the post-market surveillance process for products on the market

- Write post-market surveillance documentation e.g. PMS plans and periodic safety update report (PSUR)

- Participate in projects for changes to products (design, manufacturing, labelling) to ensure regulatory compliance

- Create and maintain regulatory documentation for products on the market

- Create country submissions and drive question answering to ensure fast approval in markets

- Develop and maintain procedures and instructions within Regulatory Affairs

- Support and participate as subject matter experts in audits (internal/external)

What we offer

We offer an organization with short lines of decision-making where you will have a unique opportunity to influence your own job. You will be part of a dynamic and high-performing team, where things sometimes go fast and where we continuously improve our processes. We solve our tasks with a high degree of professionalism and ambitions. We care for each other, and there is always room for laughter.

About you

You have a master’s degree in natural science (biomedical, engineering or similar) and you have experience working with medical devices, preferable electronic and software devices.

Your professional qualification includes

• Experience working with ISO 13485 and regulatory requirements for medical devices including MDR, FDA CFR 21 part 820

• Basic understanding of design controls and applicable standards and guidelines

• Experience with regulatory submissions

• Knowledge about vigilance and post-market surveillance processes

On a personal level, you are passionate, eager to learn and take on new challenges at a high pace. As we are a small company it is important that you are pragmatic with an open mindset and communicating approach. You are a team player, and you thrive with driving tasks independently all the way to the finish line.

Contact

For more details about the job, please contact Senior Director QA/RA, Camilla Wismar, at +[xxxxx].

Application

Deadline: 8. September 2024

All applications must be in English and are treated confidentially. We will screen and invite candidates for interviews on an ongoing basis so please send your application and CV as soon as possible.

About [xxxxx] A/S

[xxxxx] A/S is an entrepreneurial and ambitious company specializing in providing the epilepsy community with more accurate knowledge of seizures to support improvement in epilepsy care, ultimately aiming at improving patients’ quality of life.

[xxxxx] A/S was founded in 2005 and is today owned by the families behind the large hearing aid company WS Audiology. We currently employ approximately 70 people in Europe – the majority of these are situated in our headquarters in Allerød, Denmark. Our employees represent various cultures, backgrounds, skills, and years of experience.

Are you looking for new challenges? Would you like to be part of a great team with a broad range of regulatory tasks and a place where we learn as part of our journey? Then [xxxxx] might be your next career move!

[xxxxx] is a small company specializing in the technology of ultra long-term ( 30 days) subcutaneous electroencephalogram (EEG) monitoring contributing to epilepsy management. We are currently on the market in EU, Switzerland and United Kingdom (UK) and have an ongoing clinical investigation (IDE) in the United States.
We are looking for a Regulatory Affairs Specialist to join our Quality Assurance and Regulatory Affairs department. In Regulatory Affairs, our key focus is to ensure compliance with legislation and guidance for medical devices to support our product portfolio and business strategies. We monitor external requirements, evaluate complaints for reportability (vigilance), write post-market surveillance documentation, prepare regulatory device submissions, and communicate with partners and authorities worldwide.
Your main responsibilities will be
Your main responsibilities will be
Your main responsibilities will be
- Daily evaluation of customer complaints for reportability
- Vigilance reporting to authorities
- Drive and facilitate the post-market surveillance process for products on the market
- Write post-market surveillance documentation e.g. PMS plans and periodic safety update report (PSUR)
- Participate in projects for changes to products (design, manufacturing, labelling) to ensure regulatory compliance
- Create and maintain regulatory documentation for products on the market
- Create country submissions and drive question answering to ensure fast approval in markets
- Develop and maintain procedures and instructions within Regulatory Affairs
- Support and participate as subject matter experts in audits (internal/external)
What we offer
What we offer
What we offer
We offer an organization with short lines of decision-making where you will have a unique opportunity to influence your own job. You will be part of a dynamic and high-performing team, where things sometimes go fast and where we continuously improve our processes. We solve our tasks with a high degree of professionalism and ambitions. We care for each other, and there is always room for laughter.
About you
About you
About you
You have a master’s degree in natural science (biomedical, engineering or similar) and you have experience working with medical devices, preferable electronic and software devices.
Your professional qualification includes
Your professional qualification includes
Your professional qualification includes
• Experience working with ISO 13485 and regulatory requirements for medical devices including MDR, FDA CFR 21 part 820
• Basic understanding of design controls and applicable standards and guidelines
• Experience with regulatory submissions
• Knowledge about vigilance and post-market surveillance processes
On a personal level, you are passionate, eager to learn and take on new challenges at a high pace. As we are a small company it is important that you are pragmatic with an open mindset and communicating approach. You are a team player, and you thrive with driving tasks independently all the way to the finish line.
Contact
Contact
Contact
For more details about the job, please contact Senior Director QA/RA, Camilla Wismar, at +[xxxxx].
Application
Application
Application
Deadline: 8. September 2024
All applications must be in English and are treated confidentially. We will screen and invite candidates for interviews on an ongoing basis so please send your application and CV as soon as possible.

About [xxxxx] A/S
About [xxxxx] A/S
About [xxxxx] A/S
About [xxxxx] A/S
[xxxxx] A/S is an entrepreneurial and ambitious company specializing in providing the epilepsy community with more accurate knowledge of seizures to support improvement in epilepsy care, ultimately aiming at improving patients’ quality of life.
[xxxxx] A/S is an entrepreneurial and ambitious company specializing in providing the epilepsy community with more accurate knowledge of seizures to support improvement in epilepsy care, ultimately aiming at improving patients’ quality of life.
[xxxxx] A/S was founded in 2005 and is today owned by the families behind the large hearing aid company WS Audiology. We currently employ approximately 70 people in Europe – the majority of these are situated in our headquarters in Allerød, Denmark. Our employees represent various cultures, backgrounds, skills, and years of experience.
[xxxxx] A/S was founded in 2005 and is today owned by the families behind the large hearing aid company WS Audiology. We currently employ approximately 70 people in Europe – the majority of these are situated in our headquarters in Allerød, Denmark. Our employees represent various cultures, backgrounds, skills, and years of experience.