Regulatory Affairs Specialist - Medical Devices
Are you an expert of regulatory affairs and interested in medical wearables? Do you want to work in a fast growing startup producing world leading sensor technology for hot wearable health and medical markets?
PulseOn is looking for an experienced regulatory specialist to join our international team of about 15 people, located in Helsinki and Tampere in Finland and in Neuchâtel in Switzerland. You will act as the main regulatory officer and guide our team and outsourced resources to comply with the latest medical regulations.
* Set-up and perform registration and certification processes for medical devices business
* Accountable for regulatory strategy, deliverables, and results to support new product development
* Responsible for accurate documentation
* Provide regulatory guidance to other functions like R&D, Marketing, Operations and Legal
* Certificates tracking and update in time according to business needs
* Lead audits and interact with external regulatory agencies
* Stay up-to-date of regulatory standards and communicate relevant information within the team
You will be situated in our Espoo office, but willingness to travel is required.
What do we offer?
1. Becoming a key member in a very fast paced team working on cutting edge wearable technology
2. Ability to put your regulatory skills into use with a demanding target
3. Opportunity to work with world class international customers
4. Competitive salary and compensation package
Skills & Requirements
* Regulatory affairs experience in the Medical Device industry or related regulated industry is required
* Solid knowledge of applicable international regulations and standards (CE / FDA)
* Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
* Excellent written and oral communication skills
Good to have
* Interest in wearables, medical / health as an application area
* Strong organizational, problem-solving, and analytical skills
* Team-oriented and self-motivated
* Attention to detail
* Proficient on Microsoft Office (Word, Excel and PowerPoint)
Qualified and interested?
Please send your application and CV to: email@example.com
We will fulfill the position when a suitable candidate is found.
For additional information, please call our CEO, Jaakko Hattula (+358 40 8036771), on Monday 28, August 13:00 – 15:00 or Wednesday 30, August 09:00 – 11:00 (Finnish Time)