Senior Vice President Quality Assurance and Regulatory Affairs

Job title:

Senior Vice President Quality Assurance and Regulatory Affairs

Company

PeakSearch

Job description

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Jag samtycker till att kommunikation med mig sker via den e-postadress jag lämnar. Uppgifter behandlas enligt Dataskyddsförordningen (GDPR).Stäng Spara och gå vidareAMRA Medical is a health informatics company at the forefront of medical imaging and precision medicine. The company has developed a new global standard in body composition analysis, delivering multiple fat and muscle biomarkers with unrivaled accuracy and precision – all from a rapid whole-body MRI scan.AMRA offers clinical services and research services to support transformative care and vital decision-making, from clinical research to clinical care.Headquartered in Sweden, AMRA was founded in 2010 as a spin-off of Center for Medical Image Science and Visualization (CMIV), the Department of Biomedical Engineering (IMT), and the Department of Medicine and Health (IMH) at Linköping University, Sweden.Our Mission
is to confront our global health challenges by establishing the foundation for body composition measurement and providing the knowledge to predict and prevent diseases.Our Vision
is a new, fundamental way of thinking about health. We provide knowledge to the medical community so that every individual can become – and stay – healthy.Ansök härSenior Vice President Quality Assurance and Regulatory AffairsWe are looking for a driven QA & RA leader with a strategic, communicative, analytical and structured way of working.AMRA Medical is currently in an exciting growth phase taking the next steps for further developing the company in the global market.High commercial potential globally
AMRA Medical offers “The New Global Standard In Body Composition Analysis”, that has a high commercial potential globally. The company has an established business model focusing on SaaS solutions for Obesity and Metabolic Research and
Musculoskeletal and Neuromuscular Disorder Research (Pharma and Biotech Industry).AMRA Medical has solid finances for the long-term commercial development of the company. Customers include iCRO/CRO’s, leading obesity, diabetes, cardiovascular, musculoskeletal companies, biotech companies, academia and KOL’s
The AMRA technology is validated and implemented on the major MRI manufacturer platforms from GE Healthcare, Siemens Healthineers, and Philips Medical.Senior Vice President QA & RA
We are now recruiting the Senior Vice President Quality Assurance and Regulatory Affairs (SVP QARA), a key position with focus on leading the QA & RA work as a vital part on AMRAs continued development journey in the global market.Position overview:
The SVP QARA is the overall responsible for the Quality Management System and Regulatory Compliance of products and services at AMRA Medical.SVP QARA is a member of the management team and contributes to strategic work in the company.SVP QARA is the Management Representative for our QMS (ISO 13485) as well as the PRRC for our medical devices (MDR)The SVP QARA is leading the the QA & RA department at AMRA MedicalLocation: AMRA Medical HQ, Linköping or Hybrid. Be present frequently at AMRA Medical HQ (Linköping, Sweden).General information about the QA & RA team:
The current QARA team consists of two persons, working in close collaboration with each other and the entire AMRA team to promote quality awareness in the organization and to nurture continuous improvements of everyday work.Role opportunities

• Be part of a growing global company with valuable high technology products and a high market potential
• Make a great difference for patients, healthcare and research
• Become a key strategic leader for the global upscaling and development of the company
• Be part of an exciting development journey together with a highly professional and dedicated team
• Opportunity for personal competency development in relation to RA & QA for pharmaceuticals, medical devices and medtech software
• Work in an attractive company culture built on trust, open dialogue, continuous improvements, science, entrepreneurship and collaboration
• Opportunity to influence, develop and be part of a long-term incentive plan
• Good work-life balance, Good possibility to combine work and family-life, flexible working hours, extensive health benefits, social activities, training sessions etc.

Profile
We are looking for a driven QA & RA leader with a strategic, communicative, analytical and structured way of working.Experience and qualifications

• Solid experience from QARA in a leadership or project leadership role within medical devices software
• Proven experience in Quality assurance of software in regulated products, e.g. strong knowledge in ISO 13485, IEC 62304 and ISO 14971 from the medical device industry
• Experience from roles including PRRC (Person Responsible for Regulatory Compliance according to MDR or IVDR) is beneficial
• Knowledge of Good clinical practice (GCP) in clinical trials of medical devices or pharmaceuticals is a plus
• Fluent in professional English
• University degree in Science, Medicine or Engineering

Key competencies & personality

• Excellent strategic and analytical ability
• Communicates well, verbally and in writing
• Pedagogic approach
• High sense of structure
• Leadership skills
• Change management ability
• Goal driven
• High self-awareness
• Robust personality
• Project management skills

PeakSearch contact
For more information and dialogue about the SVP QARA position, please contact Magnus Klingberg, Sr Recruitment Consultant at PeakSearch.Magnus Klingberg
Senior Recruitment Consultant
magnus.klingberg@peaksearch.se
+46(0)70-678 09 92

Expected salary

Location

Linköping, Östergötland

Job date

Sat, 18 Jan 2025 01:45:13 GMT

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