Medical Device Assessors
4 weeks ago
This position has continuous, ongoing recruitment efforts for current and future openings. Applying for this role will gain you consideration for all roles within this opening which you are qualified for.
As part of our continued growth, we are looking to recruit technical and experienced Non-Active Medical Device Assessors and Lead Auditors throughout Europe. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, MDD 93/42/EEC, MDR 745/2017 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.
Responsibilities:
Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and time-frames to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation as requested by the Medical Devices Operations Manager. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.
• Colleagues with high technical and regulatory skills.
• Work environment with high focus on well-being and high standards for personal and professional development.
• Challenging and attractive position with professional development through work and training.
Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below.
Non-Active devices
Biology or Microbiology Biomechanical Engineering Chemistry or Biochemistry Dentistry Human Physiology Materials or Biomaterials Science Medical Technology Medicine, Veterinary Medicine Nursing Pharmacy, Pharmacology, Toxicology Physics or Biophysics PhysiologyIn addition to a relevant educational degree, candidates must have a minimum 4 years’ work experience (full time) in a medical device related industry, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit / Assess, and/or experience as an assessor in a notified body (full five technical documentation assessments).
As part of this work experience, risk management experience should be covered:
Practical experience in conducting pre-clinical testing or assessing pre-clinical data with medical devices in one or more of the following areas such as biological safety, physical, chemical and microbiological characterization, stability, shelf life, performance and safetyA PhD in a relevant area for medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing.
To be considered for this role, you will have professional experience in a relevant field of healthcare products or related activities, for example:
Work in medical devices industry or closely related industries (. pharmaceutical industry) in a research and development, manufacturing, quality management or regulatory affairs capacity Work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies Work in the application of device technology and its use in health care services and with patients Testing devices for compliance in accordance to the relevant national or international standards Conducting performance testing, evaluation studies or clinical trials of devicesIn addition to the above you’ll also need to demonstrate the following;
An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Work experience in positions with significant QA Regulatory or management systems responsibility Experience with Harmonized medical device standards for active & non active medical devices Experience with Risk Management EN ISO 14971 Experience with Sterilization techniques (such as ETO, Gamma, Steam, Dry Heat) and formal qualification desirable Medical device experience from auditing/work Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of medical devices Should have a flair for technical writing, essential for exhaustive report writingIf you're interested in applying, please submit your CV and cover letter in English.
Kindly be informed you may be requested to provide DNV with additional documents for a background check.
Successful candidate can be based in any EU country where DNV has an office. You will be hired on local conditions.
Interviews will be held on an on-going basis.
-
Medical Device Assessors
3 months ago
Stockholm, Sweden DNV Full timeThis position has continuous, ongoing recruitment efforts for current and future openings. Applying for this role will gain you consideration for all roles within this opening which you are qualified for. As part of our continued growth, we are looking to recruit technical and experienced Non-Active Medical Device Assessors and Lead Auditors throughout...
-
Global Regulatory Affairs Manager
1 month ago
Stockholm, Sweden Karo Healthcare Full timeKaro Healthcare, a dynamic and growing company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 100 brands in about 90 countries. Our portfolio includes such brands as E45, Pevaryl, Lamisil, Nutravita, Decubal and many others. Our core belief in...
-
Global Regulatory Affairs Manager
4 weeks ago
Stockholm, Sweden Karo Healthcare Full timeKaro Healthcare, a dynamic and growing company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 100 brands in about 90 countries. Our portfolio includes such brands as E45, Pevaryl, Lamisil, Nutravita, Decubal and many others. Our core belief in...
-
Senior Project Engineer – Medical Devices
2 weeks ago
Stockholm, Stockholm, Sweden Intertek Full timeAbout us: Intertek is a Nationally Recognized Testing Lab (NRTL) and trusted provider of quality and safety solutions to many of the world's leading brands, companies, and governments. With more than 46000 colleagues around the world we play a major role in testing and certification globally. We help ensure safety of electrical products by providing services...
-
Principal Medical Writing Consultant
4 weeks ago
Stockholm, Sweden ProPharma Group Full timeFor the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners...
-
Principal Medical Writing Consultant
2 weeks ago
Stockholm, Stockholm, Sweden ProPharma Group Full timePrincipal Medical Writing Consultant page is loaded Principal Medical Writing Consultant Apply locations London Belgrade Zagreb Stockholm Lund time type Part time posted on Posted 30+ Days Ago job requisition id JR 4232 For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech,...
-
Medical Manager, Nordics
2 weeks ago
Stockholm, Stockholm, Sweden Haeger & Carlsson Full timeDo you thrive in collaborative environments where innovation and strategic thinking are valued?On behalf of BD we are recruiting a Medical Manager Nordics. BD is one of the largest global medical technology companies and is advancing the world of healthTM by improving medical discovery, diagnostics and the delivery of care. BD and its 75,000 employees are...
-
Medical Advisor Radiology, Nordics
2 weeks ago
Stockholm, Stockholm, Sweden Haeger & Carlsson Full timeAre you passionate about bridging the gap between scientific innovation and medical practice? On behalf of Bayer we are recruiting a Medical Advisor Radiology, Nordics.Bayer is a global enterprise with core competencies in the life science fields of healthcare and agriculture. They design their products and services to help tackle some of the world's biggest...
-
Multilingual Medical Information Specialist
3 days ago
Stockholm, Sweden ProPharma Group Full timeFor the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners...
-
Stockholm, Stockholm, Sweden Samplimy Medical AB Full timeAre you passionate about pioneering groundbreaking medical solutions? Do you want to contribute to building a business that will help millions of patients and healthcare professionals worldwide? Then join our dynamic team as a potential co-founder and Head of Operations ABOUT USWe are a MedTech startup company born as a spin-off from KTH Royal Institute of...
-
TS Field Engineer
2 weeks ago
Stockholm, Stockholm, Sweden Baxter Medical AB Full timeThis is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter's products and therapies are found in almost...
-
Complaint and process Specialist
2 weeks ago
Stockholm, Stockholm, Sweden Boule Medical AB Full timeBoule Diagnostics AB är ett globalt diagnostikbolag som utvecklar, tillverkar och säljer system och förbrukningsvaror för blodcellräkning (hematologi). Bolaget riktar sig främst till små och medelstora sjukhus, kliniker och laboratorier samt till andra diagnostikbolag inom såväl human- som veterinärhematologi. Verksamheten bedrivs genom...
-
Technical and Manufacturing Manager
2 weeks ago
Stockholm, Stockholm, Sweden Navamedic ASA Full timeIf you have expertise in tablet technology and want to join an exciting pharma company in growth and development, keep readingNavamedic is going through an exciting period of growth, acquiring ownership of products with global market potential. They are now seeking an experienced and highly skilled professional in the manufacturing and quality/technical...
-
Technical Planning Associate
2 weeks ago
Stockholm, Stockholm, Sweden Intertek Full timeKey role: In the journey with the Medical Device Regulation (MDR), we need a Technical Planning Associate to bolster our Notified Body.Responsibilities:Guide projects for clients and ensure accurate technical planning activities.Ensure compliance with ISO17021 Accreditation, EU Medical Device Regulation (EU) 2017/745, ISO13485, MDSAP, UKCA, UKAS, and other...
-
Stockholm, Stockholm, Sweden Stryker Full timeWhy join Stryker?We are proud to be named one the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine Learn more about our award-winning organization by visiting Our total rewards package offering includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards –...
-
Senior Quality Assurance Manager
2 weeks ago
Stockholm, Stockholm, Sweden EPM Scientific Full timeJoin Our Team as a Senior QA Manager Location: NordicsCompany: Our client is a Top Medical Device OrganisationJob Type: HybridDate: URGENT To be shortlisted ASAPAbout Us:Step into the future of healthcare with a leading medical devices company that's redefining innovation and quality. We're committed to improving patient outcomes and delivering cutting-edge...
-
Manager at Product Development
2 months ago
Stockholm, Sweden Cowboys Unica All Jobs Full timeSHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5 000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their...
-
Manager at Product Development
2 weeks ago
Stockholm, Stockholm, Sweden Cowboys Unica All Jobs Full timeSHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5 000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their...
-
Manager at Product Development
4 weeks ago
Stockholm, Sweden Cowboys Unica All Jobs Full timeSHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5 000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their...
-
Customer Care Technical Engineer
2 weeks ago
Stockholm, Stockholm, Sweden Boule Medical AB Full timeBoule Diagnostics AB är ett globalt diagnostikbolag som utvecklar, tillverkar och säljer system och förbrukningsvaror för blodcellräkning (hematologi). Bolaget riktar sig främst till små och medelstora sjukhus, kliniker och laboratorier samt till andra diagnostikbolag inom såväl human- som veterinärhematologi. Verksamheten bedrivs genom...
