Medical device QA/RA Consultant

2 months ago

København, Denmark The HubDanske Bank Full time

This is a temporary consultancy position to support while we search for a permanent hire

Do you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations for a while and now you would like to work more holistically with every part of a QMS system. Maybe you are a seasoned QA specialist that would like to endeavour into the field of medical device software. If that is the case, then you could be the colleague we are looking for.

You will help define and deliver on our strategy to maintain superior product quality and take lead on placing our products on new markets

As a QA/RA specialist in Radiobotics you will become the expert in all corners of our Quality Management System. You will be engaged in all stages of product development and help define structure of the technical documentation, as well as ensuring our internal quality processes are well-oiled. You will play a central role in placing products into new markets, be pivotal in maintaining our products in existing markets and you will take part in audits from notified bodies and authorities.

Your main tasks will be:
  • Co-driving product release projects in collaboration with the project manager from the development team
  • Supporting other departments in design control
  • Take lead on the risk analysis for new products, with support from our clinical and development team
  • Reviewing and revising QMS procedures to ensure that they are efficient and effective
  • Assist management in prioritizing regulatory approval activities based on strategy and market potentials
  • Creating and coordinating the product submissions for the devices we develop (possibly supported by consultants)
  • Training of the company in QMS procedures
  • Participate in audits, both internal and external

After two weeks...

You’ll already know all your new colleagues, who do what within Radiobotics, and who can help you out when you feel lost. Moreover, you will have enjoyed a few delicious breakfasts and Friday bars. You’ll be up and running with your new computer and will be familiar with our products and previous QA/RA projects.

After 1 month…

You’ll be working on the first design control project, and perhaps participate in risk management activities. You will have had a few 1:1 meetings with your manager and your latte art game will be on point. You’ll start naming everything in your life with the RB prefix (like our products).

After 3 months...

You’ll be participating in audits, driving CAPAs and communication with authorities across the world. You will also have a plan for further development of your professional quality and regulatory affairs skillset. You will have participated in a few RB activities outside the office and have your personal ranking of your favorite almond croissants in the city.

After 6 months...

By this date, you won’t be the RBrookie anymore, so you’ll be the lead in our technical documentation and have reviewed and approved most types of procedures and quality records. You have played a significant role in our strategy to reach new markets and will be the go-to-person for questions around topics like product submissions, validation efforts and record control. Depending on the timing, you’ll have attended a work-away, won an RBmusic-quiz and you will have developed competitive Foosball/Petanque skills you didn’t know you had.

Qualifications

You have at least 1 year experience within quality assurance and/or regulatory affairs, and you know that working with quality and regulatory processes within the medical device field is the right path for you. You pay great attention to detail and your ability to structure your tasks efficiently means that you deliver on time.

The ideal candidate will furthermore have

  • A master’s degree in healthcare, medical or life science
  • A positive can-do attitude with a thorough and structured mindset
  • Excellent communication skills in English and experience with working within or leading cross-functional projects
  • Knowledge of quality management systems and regulatory requirements within MDR and ISO 13485, and ideally 21 CFR
  • Experience with Software as a Medical Device

You will join the Clinical and Regulatory team and will be referring to our Chief Clinical and Scientific Officer. We are looking for someone who can work both independently, and as part of a cross-functional team, in a changing and dynamic environment with tight deadlines. You should be good at planning, coordinating and managing stakeholders during design and development activities and product submissions.

We are Radiobotics

At Radiobotics we do what we say. To us that’s integrity. We also believe in transparency. In always keeping our doors open and communicating with honesty. We are driven by aspiration, curiosity and playfulness. Because we are not afraid of pursuing big ideas. We strive to learn what happens beyond the surface. And we show up every day, ready to engage and have fun with each other. This is us. We are Radiobotics.

We are on a mission to solve the global need for radiologists while ensuring every patient receives expert level care. Our vision is that all routine X-rays of the musculoskeletal system are augmented and 1st line reported by our products. This will enable the reading of radiology images by non-specialists assisted by our products and ensure that patients have access to immediate expert-level evaluation of their imaging and ultimately facilitate that non-critical imaging is safely and effectively handled outside the hospital.

#J-18808-Ljbffr

  • Medical device QA/RA Consultant

    2 months ago

    København, Denmark Radiobotics ApS Full time

    Radiobotics Copenhagen Freelance Part-time Salary Competitive This is a temporary consultancy position to support while we search for a permanent hire Do you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations...

  • Medical device QA/RA specialist

    2 months ago

    København, Denmark Radiobotics ApS Full time

    Radiobotics Copenhagen Full-time Salary Competitive Do you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations for a while and now you would like to work more holistically with every part of a QMS system. Maybe...

  • Medical device QA/RA specialist

    2 months ago

    København, Denmark The HubDanske Bank Full time

    Do you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations for a while and now you would like to work more holistically with every part of a QMS system. Maybe you are a seasoned QA specialist that would like to...

  • Senior Manager, RA Processes, Systems and Tools

    2 months ago

    København, Denmark Radiometer Danmark Danaher Full time

    In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating...

  • Associate Director Medical Devices Lifecycle Management

    3 weeks ago

    København, Denmark Internetwork Expert Full time

    Want a 3D Career? Join Norgine. At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community. We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits. Bring everything about yourself that you’re proud of, whether...

  • Manufacturing QA Engineer

    23 hours ago

    København, Denmark Agilent Technologies, Inc. Full time

    Manufacturing QA Engineer We are looking for a new team member. Join us! Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they...

  • Field Service Engineer

    1 week ago

    København, Denmark Stryker Corporation Full time

    Field Service Engineer - Medical Devices We are looking for an autonomous, dedicated individual to join our team as a Nordic - Mako Field Service Representative . As this is a field-based role for the Nordic region, you should be based in the Copenhagen Region of Denmark. The responsibilities of the Mako Field Service Representative include undertaking...

  • Software Developer

    23 hours ago

    København, Denmark The HubDanske Bank Full time

    Please Note: Only applicants currently living within commuting distance to our office will be considered. The Company Perfusion Tech is a pioneering MedTech startup, founded in 2016 and headquartered in Copenhagen, at the forefront of blood perfusion analysis. Our mission is to assist surgeons in the operating room to save lives, reduce surgery time, and...

  • Medical Lead

    2 months ago

    København, Denmark Novartis Full time

    About the Role Your Key Responsibilities: Your responsibilities include, but are not limited to: Ensure medical enquiries are responded to in a high quality, timely manner, and in accordance with applicable standards; establish standard response documents as appropriate, for frequently asked questions. Provide medical/scientific input into the development...

  • Medical Lead

    2 months ago

    København, Denmark Advanced Accelerator Applications (Italy) - S... Full time

    Location: Copenhagen, Hybrid. (40 - 50% field)In line with overall product strategy, the Medical Lead is responsible for supporting the design, implementation and execution of Medical Affairs plans for assigned Therapy Area, providing scientific information, helping design & organize clinical studies, building informative dialogue with KOLs and regulatory...

  • Senior QA Engineer

    2 months ago

    København, Denmark Corti Full time

    There is no quality healthcare without a quality dialogue. Today, that dialogue is broken; we need you to help us fix it. Doctors and nurses across the world are facing unprecedented challenges. When we meet them, they're dealing with heavy workloads, extensive paperwork, and the pressure of performing well, which in healthcare, can have dire consequences....

  • Experienced Global Product Manager

    2 months ago

    København, Denmark Ambu AS Full time

    Experienced Global Product Manager - Cardio and Neuro City: BallerupCountry: DenmarkBusiness Area: MarketingDepartment: Global Product Management, A&PMEmployment Type: Full-time Ambu A/S is currently looking for an Experienced Global Product Manager for Patient Monitoring within Cardio and Neurology to be based in Ballerup, Copenhagen. The role is reporting...

  • Medical Advisor

    2 months ago

    København, Denmark Radiometer Danmark Danaher Full time

    In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating...

  • QA and Validation Engineer Denmark Copenhagen

    2 months ago

    København, Denmark DIS - CREADIS Engineering Solutions & Consulting Full time

    We are experiencing significant growth and are seeking additional colleagues to focus on QA and validation tasks for a wide range of customers within the life science industry. Together with skilled colleagues, you will take part in the exciting journey! Your Role in Future Projects As an employee at DIS, you will become part of an ambitious environment...

  • CV/QA Specialist, Copenhagen, Denmark

    2 months ago

    København, Denmark emagine Consulting AS Full time

    Join our team as a QA/CV Sourcing Specialist in Copenhagen, Denmark! Are you ready to drive impactful changes for some of the top-tier IT freelancers in Denmark and across Europe? Come aboard our dynamic Sourcing Back Office team and step into the role of a QA/CV Sourcing Specialist in the rapidly expanding IT industry! As a QA/CV Sourcing Specialist, your...

  • QA & Support Specialist

    2 months ago

    København, Denmark Teton.ai Aps Full time

    Quality Assurance Full-time Copenhagen, DK Teton is building AI technology that empowers nurses and frontline care staff to deliver more effective care with less stress. Our solution helps hospitals and care homes maintain critical care standards and patient safety, addressing the global nursing shortage with innovative AI tools. At Teton, we operate...

  • Scientist, QA Manufacturing Support

    2 months ago

    København, Denmark AGC Inc Full time

    Scientist, QA Manufacturing Support Apply locations: Copenhagen, Denmark Time type: Full time Posted on: Posted 29 Days Ago Job requisition id: JR100828 Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in...

  • Medical Writer DK Copenhagen

    3 weeks ago

    København, Denmark Globant Full time

    We are a digitally native technology services company where innovation, design and engineering meet scale. We use some of the latest technologies in the digital and cognitive field to empower organizations in every aspect. Vertic, a Globant division, is currently looking for a Medical Writer to join its Globant Gut Studio in Copenhagen. You will get the...

  • Full stack Developer/QA Engineer

    2 months ago

    København, Denmark ReFlow Full time

    ReFlow Remote Work Freelance Salary Competitive Are you passionate about sustainability and eager to apply your technical skills to make a real impact? ReFlow, a leading environmental engineering firm, seeks a motivated and talented Sustainability Data Scientist to join our team for the summer of 2024. At ReFlow, we specialize in lifecycle assessment (LCA)...

  • Quality Assurance Specialist

    23 hours ago

    København, Denmark Geneve Int Full time

    Quality Assurance Specialist (Regulatory) - P4 Site: Denmark, Copenhagen Sector: Nonprofit/Community/Social Services/International Cooperation Role: Other Date of last update: 2024-11-14 (Expiry date: 2024-11-26 ) For 70 years, UNICEF has been working on the ground in 190 countries to promote children's survival, protection and development. The world's...