Senior Regulatory Affairs Specialist
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Kongens Lyngby
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders.
About the job
BK Medical is looking for Regulatory Affairs Senior Specialist with drive and energy to join our Regulatory Affairs team. It is a new position in a rapidly increasing organization. You will be part of our global team who are in Denmark (Herlev), USA (Boston) and in China (Shanghai).
We are looking for a new team member with a positive and proactive mindset. You thrive in an international environment with a high pace. You enjoy being part of a committed team and take pride in finalizing the tasks together with the team.
In this position you will drive global registrations of innovative products around the globe and be part of the group who ensure that BK Medical products are timely registered to be provided to our global customers. You will plan RA strategy, author and execute documents with the aim of registering products Class I - III globally.
You will work closely with the Global Regulatory team as well as Product Marketing, Sales Distribution and R&D.
You:
Who are we in RA team
Regulatory Affairs is a part the RA/QA Function belonging to the global organization with offices in Herlev, Denmark and the Global Headquarter in Boston, Massachusetts, US.
The Global Regulatory Affairs Team consists of 13 members: 3 people in US, 1 in China, 9 people in Denmark. The members of the Regulatory Affairs have a strong regulatory background within Medical Devices and are dedicated to development of safe and effective products for our global customers.
We have a great team that solve challenging tasks together. We value being professional, trustworthy, honest, communicate with one voice and being open minded. We are business oriented and take pride in guiding the organization in the complex regulatory environment.
About BK Medical
BK Medical is committed to designing ultrasound systems that help surgeons image, guide, intervene, and navigate inside the human body. Surgeons are our customers, and they range from HPB surgeons, neurosurgeons, and robotic-assisted surgeons to urologists, colorectal surgeons, and more.
Our mission at BK is to enable real-time intraoperative guidance during surgical procedures, giving surgeons the information needed to immediately make critical decisions. Our products are designed and customized for surgical procedures, to help surgeons save time and get results.
As market leaders, we work closely with experts and universities to provide the best solutions to clinical challenges.
At BK Medical, we support employees in developing their skills and expertise. We have a professional and informal organization with flexible working conditions and a flat organizational structure.
We are effective and can execute our ideas into strong products – these ingredients make BK Medical an exciting and development-oriented workplace.
At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.
About the job
BK Medical is looking for Regulatory Affairs Senior Specialist with drive and energy to join our Regulatory Affairs team. It is a new position in a rapidly increasing organization. You will be part of our global team who are in Denmark (Herlev), USA (Boston) and in China (Shanghai).
We are looking for a new team member with a positive and proactive mindset. You thrive in an international environment with a high pace. You enjoy being part of a committed team and take pride in finalizing the tasks together with the team.
In this position you will drive global registrations of innovative products around the globe and be part of the group who ensure that BK Medical products are timely registered to be provided to our global customers. You will plan RA strategy, author and execute documents with the aim of registering products Class I - III globally.
You will work closely with the Global Regulatory team as well as Product Marketing, Sales Distribution and R&D.
You:
- Degree on bachelor level in medical science, engineering or equivalent knowledge
- More than 5 years’ experience in a similar position in an international medical device company.
- Have experience with making Regulatory Strategies during development of new products as well as ensuring CE marking, FDA clearance and product registration
- Experience in software/digital fields preferred
- Experienced in cooperation with relevant national health authorities, Notified Body
- Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills
- Fluent in oral and written in English as a working language
Who are we in RA team
Regulatory Affairs is a part the RA/QA Function belonging to the global organization with offices in Herlev, Denmark and the Global Headquarter in Boston, Massachusetts, US.
The Global Regulatory Affairs Team consists of 13 members: 3 people in US, 1 in China, 9 people in Denmark. The members of the Regulatory Affairs have a strong regulatory background within Medical Devices and are dedicated to development of safe and effective products for our global customers.
We have a great team that solve challenging tasks together. We value being professional, trustworthy, honest, communicate with one voice and being open minded. We are business oriented and take pride in guiding the organization in the complex regulatory environment.
About BK Medical
BK Medical is committed to designing ultrasound systems that help surgeons image, guide, intervene, and navigate inside the human body. Surgeons are our customers, and they range from HPB surgeons, neurosurgeons, and robotic-assisted surgeons to urologists, colorectal surgeons, and more.
Our mission at BK is to enable real-time intraoperative guidance during surgical procedures, giving surgeons the information needed to immediately make critical decisions. Our products are designed and customized for surgical procedures, to help surgeons save time and get results.
As market leaders, we work closely with experts and universities to provide the best solutions to clinical challenges.
At BK Medical, we support employees in developing their skills and expertise. We have a professional and informal organization with flexible working conditions and a flat organizational structure.
We are effective and can execute our ideas into strong products – these ingredients make BK Medical an exciting and development-oriented workplace.
At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.
Information og data
Denne ledige stilling har jobtypen "Jurist", og befinder sig i kategorien "Økonomi og jura".
Arbejdsstedet er beliggende i Kongens Lyngby.
Jobbet er oprettet på vores service den 3.11.2021, 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.
- Jurist
- Kongens Lyngby
- Fredag den 28. januar 2022
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