Regulatory Affairs Manager (HQ position)

In line with Perimed’s expansion plans, regarding both new products and new markets, the company is establishing a new position as Regulatory Affairs Manager. This is an exciting opportunity to take on global responsibility for strategic and operative tasks in a growing company, with headquarter in Sweden. It is an independent operating role where you will have support from especially the Head of Quality Assurance & Regulatory Affairs.

Overall tasks:

• Enable Perimed expansion through management of registration activities in new markets and registration of new products on current markets.
• Secure continued sales on current Perimed markets by maintaining regulatory compliance related to product changes and updated regulations.
• Manage communication with regulatory authorities and distributors on regulatory matters.
• Represent regulatory affairs in new product development and maintenance projects.
• Create and maintain product related regulatory documentation.
• Monitor regulatory requirements on Perimed markets.
• Initiate and make changes in the Perimed management system to maintain compliance with relevant regulatory requirements.
• Contribute to and handle process improvement.
• Handle communication within the organization e.g. with Sales and with customers, when there are questions regarding regulatory matters.
• Perform Post-Market Surveillance of Perimed products and initiate improvement actions.

Overall responsibilites:

• Manage new product registrations and maintain current product registrations.
• Communicate with regulatory authorities.
• Initiate and make changes in the Perimed management system due to changed regulatory requirements.
• SOP’s within product registrations and reporting to authorities.

Background of successful candidate:

Required:

• At least five years experience within the Medical Device industry.
• At least two years experience within Medical Device Regulatory Affairs.
• Background from development and production based environment.
• Knowledge on medical device regulations.
• Ability to interpret the regulations in different countries.
• High degree of integrity and responsibility and ability to work independently of others.
• Able to speak and write fluently in English and Swedish.
• Ability to communicate effectively with global regulatory authorities and distributors.
• Organized, structured, and accurate way of working. Strong analytical skills.
• Education: University degree in engineering or science.

Preferred:

• Good knowledge on medical device regulations in Europe, USA and China, e.g. ISO 13485, FDAs GMP, MDD and MDR, NMPA regulations in China.
• Knowledge on technical product standards.
• Good knowledge on environmental regulations, e.g. RoHS and REACH.

To apply, please send your CV to Daniel Kremer (daniel.kremer@moveup.se) as soon as possible!