AprioMed AB
AprioMed develops, manufactures, markets and sells innovative medical devices and related services within the field of interventional radiology. We aim to deliver, in close collaboration with healthcare practitioners, innovative quality tools to achieve the most favourable solutions for radiologists worldwide.
AprioMed is headquartered in Uppsala Business Park, Sweden. Our products are sold in more than 40 countries by AprioMed (direct sales in UK, Ireland and Sweden) and our local distributors.
Further information about the company can be found on: http://www.apriomed.com
Quality and Regulatory Affairs Manager
This is an opportunity to work in a key position at AprioMed with the great opportunity to build, lead and develop the quality- and regulatory initiatives for the company to secure success in the future, and to contribute to the company´s future growth and development.
AprioMed is looking for a person with a solid experience of regulatory, including submission to authorities of medtech products in different markets (particularly in Europe and USA), preferable from a small/medium size company engaged in product development. The Quality and Regulatory Affairs Manager shall assure quality on products and processes by establishing and enforcing quality standards within the entire company.
Job Title: Quality and Regulatory Affairs Manager
Reports to: CEO
Location: Uppsala
Responsibilities and tasks
• ensuring that regulatory strategies and associated activities are effectively executed to meet the business objectives and legal requirements
• the complete quality management system, ensure that it operates effectively within appropriate quality standards
• develop plans concerning what kind of verifications the products are expected to undergo during development, how it should / can be manufactured, transported, etc. to meet each specific market requirements
• act as manager for 1 Quality Assurance Specialist
Profile
We are looking for a person with a strong desire to join a small company and work in a fast-paced environment with freedom and flexibility, as well as high expectations. We are looking for a person with the ability to work both operational with day-to-day activities and strategic by having a comprehensive view of the company.
You need to be flexible and result oriented, and willing to work in a dynamic environment while managing multiple priorities. It is important to have strong communication skills, with the ability to communicate clearly and effectively both inside and outside the organization. We are looking for an ambitious person with a personal drive to take responsibility, and with the ability to work both independently and together with others to deliver results.
Experience and qualifications
• Relevant University Degree
• Experience from a Medical Device company, and with ISO 13485
• A solid and documented experience within regulatory including submission to authorities of medtech products in different markets (particularly in Europe and USA) -meritorious with experience from Japan
• Excellent communication skills in English. Fluent in Swedish
• Experience and an understanding of what it means to work in smaller companies in a broad role, is an advantage
Personal characteristics
• Drive and result-oriented
• Self-reliable with ability to prioritize tasks
• Confident and self-dependent with the ability to work both independently as well as working in a team
• Trustworthy and credible
• Flexible, adaptable and pragmatic
• Prestigeless
• Good interpersonal skills
• Social with the ability to give energy
• Positive “can-do” attitude
Opportunities with the role
• The possibility to work for a successful, small, growing, and innovative company and work in a fast-paced environment with freedom and flexibility, as well as high expectations
• To work in a small company with a dynamic culture, freedom of action, a nice atmosphere and collaborative environment
• Work in values-based company, deeply rooted in science and innovation to transform new ideas and discoveries
• Be part of a very competent and experienced team with high energy, all very committed to develop the company
• Work in a company with short decision paths and with a high level of personal responsibility
• To work with a broad spectrum of responsibilities in a small medtech company and to contribute to the growth of the company
• This is a key position at AprioMed with the great opportunity to build, lead and develop the quality- and regulatory initiatives for the company to secure success in the future, and to contribute to the company´s future growth and development
Contact
For more information and questions about the position, please contact Marta Frick Senior Recruitment Consultant at PeakSearch.
Contact details:
marta.frick@peaksearch.se Tel: 070-386 89 69