English
ABOUT PERIMED:
Perimeds vision is:
“To provide instruments for accurate diagnosis and monitoring of all patients with ischemia in order to save limbs, lives, costs and reduce human suffering.”
Perimed AB is a Swedish company, founded in 1981 and headquartered just outside Stockholm, that develops, manufactures and markets state-of-the-art diagnostic equipment to assess microcirculation and peripheral perfusion as well as peripheral arterial disease.
Perimed offer solutions for clinical use as well as for research. Perimed have more than 40 years of experience and unique competence in fiber optics, laser and camera optics, as well as tissue optics making Perimed a leader in measuring and assessing microcirculation and peripheral macro circulation.
Perimeds clinical tools will help you with high quality examination of Ischemia and assessment of wound healing potential for your patients. Perimeds advanced research tools will help you obtain valuable and actionable results for both clinical research and research
Perimed is a global company with subsidiaries in USA, China, France, Italy and Germany. Our customers in the other countries are supported either directly from Perimeds Swedish headquarters or by their certified local distributors listed on Perimeds contacts pages.
To deepen their understanding of diseases related to blood perfusion and microvascular functions, Perimed actively participates with leading universities in a wide range of research projects. The knowledge acquired through these projects is continuously re-invested in further product development.
TILLSATT - International Regulatory Affairs Manager
Exciting opportunity to take on global responsibility for strategic and operative tasks in a growing company, with headquarter in Sweden
Position: International Regulatory Affairs Manager
Location: The Perimed headquarters, Järfälla (option to work homebased 2 days a week)
Employment: Full time permanent employment
Department: Quality & Regulatory Affairs
Reports to: Head of Quality & Regulatory Affairs
POSITION OVERVIEW:
Perimed is looking for a International Regulatory Affairs Manager to support the continuous expansion.
Perimed is working on finalizing the top priority MDR project in 2022, and has reached the important milestone of a positive MDR audit in August 2022. The MDR project has had an extensive impact on the quality of the technical documentation for the product portfolio.
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 & Regulatory Affairs.
ESSENTIAL DUTIES & RESPONSIBILITIES:
Key responsibilities
• Enable Perimed expansion through management and execution 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 product 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
Additional responsibilities
• Monitor product regulatory requirements on Perimed markets
• Initiate and make changes in the Perimed management system to maintain compliance with relevant regulatory requirements
• 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
• Communicate with regulatory authorities
• SOP’s within product registrations and reporting to authorities
• Participate in finalizing the top priority MDR project
EXPERIENCE AND QUALIFICATIONS:
• Experience from regulatory affairs in the medical device industry alternatively experience in the medical device industry as a quality engineer/ product developer/ validation engineer/ product Manager R&D with interest in regulatory affairs
• Fluent in English (speaking and writing), Swedish is desirable
• Education: University degree in engineering or science
KEY COMPETENCIES:
• High degree of integrity and responsibility and ability to work independently of others
• Organized, structured, and accurate way of working
• Strong analytical skills
• Strong ability to deliver effectively in time with high qualit
• Excellent writer of regulatory documentation and applications
• Ability to communicate and collaborate effectively with colleagues, global regulatory authorities and distributors
• Engaged, positive, flexible and solution oriented
ROLE OPPORTUNITIES:
• Opportunity to gain extensive knowledge of global regulatory affairs within a company with top quality medical technology products
• Have a key role in an exciting development and expansion journey in a successful, leading and growing Swedish company on a global market
• Work with a team of professional, dedicated and skilled colleagues, distributors and authorities from different parts of the world
• Get broad responsibility with the opportunity to influence your work in an open, dynamic, innovative and attractive company culture with focus on professionalism, passion, accountability and collaboration
CONTACT, INFORMATION AND APPLICATION:
For more information and application please contact Andrea Backlund or Magnus Klingberg Recruitment Consultants at PeakSearch.
Andrea Backlund, Recruitment Consultant
Mob. +46 70 235 67 96
Email. andrea.backlund@peaksearch.se
Magnus Klingberg, Sr Recruitment Consultant
Mob. +46 70 678 09 92
Email. magnus.klingberg@peaksearch.se