Manager or Senior Manager, Quality and Regulatory Affairs

3 weeks ago

Gothenburg, Västra Götaland, Sweden Veranex, Inc. Full time
Manager or Senior Manager, Quality and Regulatory Affairs (Consulting)

Gothenburg, Sweden ● Stockholm, Sweden Req #201

Monday, May 13, 2024

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.

What You Will Do:

  • Provide strategic and hands on regulatory support to clients related to compliance (Reg. EU 2017/745 (MDR), Reg. EU 2017/746 (IVDR), MDSAP, ISO 13485, US CFR Title 21, QSR)
  • Assess complex scientific / technical documentation to identify gaps and to provide support for improvement
  • Manage projects in a structured way in direct contact with Clients, Competent Authorities and Notified Bodies - during audits, conformity assessments and with product specific regulatory issues
  • Coach clients on implementation and remediation activities for Quality Management Systems and technical documentation
  • Assist clients in successfully managing nonconformities, complaints, recalls, FSN, FSCA
  • Participate in Veranex training programs and represent Veranex in congresses and fairs

Qualifications

Required Skills:

Manager Level:

  • Graduate degree in life science, medical or engineering (MSc/PhD)
  • Minimum 3-5 years' relevant experience in Quality and/or Regulatory Affairs in relation to the medical device / in-vitro diagnostic industry
  • Good understanding of regulatory requirements for the market clearance of medical devices/in-vitro diagnostics (EU and/or USA) and/or ISO 13485 QMS implementation
  • High-level of professionalism, including strong verbal and written skills
  • Strong ability to independently manage tasks and take initiative
  • Efficient multitasking and proactive engagement across various responsibilities
  • Excellent command of Swedish and English, both oral and written (any other language skills are a plus)

Senior Manager Level:

  • Graduate degree in life science, medical or engineering (MSc/PhD)
  • 6+ years relevant experience in Quality and/or Regulatory Affairs in relation to the medical devices/in-vitro diagnostic industry
  • Strong understanding of regulatory requirements for the market clearance of medical devices/in-vitro diagnostics (EU and/or USA) and/or ISO 13485 QMS implementation
  • Experience interfacing with regulatory authorities to manage submission processes through device commercialization
  • Experience overseeing/preparing regulatory strategy packages
  • High-level of professionalism, including strong verbal and written skills
  • Strong ability to independently manage tasks and take initiative
  • Efficient multitasking and proactive engagement across various responsibilities
  • Excellent command of Swedish and English, both oral and written (any other language skills are a plus)

Preferred:

  • Experience in Quality and/or Regulatory Affairs consulting

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.

#J-18808-Ljbffr

  • Director, Clinical Affairs

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden Veranex Full time

    Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...

  • Senior Director Risk Management, Patient Safety Centre of Excellence

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden AstraZeneca Full time

    Introduction to the Role:Are you an experienced Risk Management professional with a deep understanding of patient safety? Do you excel in providing leadership and strategic guidance for the advancement of cutting-edge risk management methods, tools, and technology? If so, we have an exciting opportunity for you as the Senior Director of Risk Management. In...

  • Senior Manager Quality Compliance

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden Northvolt AB Full time

    Senior Manager Quality ComplianceAre you an experienced leader, specialized in quality competencies and with extensive knowledge in quality management systems? Would you like to play a key role in one of Europe's most exciting industrial projects? This is a unique opportunity to be involved early in the development of our organization, building a team and...

  • Senior Manager Quality Compliance

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden NOVO Energy Full time

    Filter Senior Manager Quality ComplianceAre you an experienced leader, specialized in quality competencies and with extensive knowledge in quality management systems? Would you like to play a key role in one of Europe's most exciting industrial projects? This is a unique opportunity to be involved early in the development of our organization, building a...

  • Regulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEA

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden IQVIA Full time

    Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...

  • Medical Affairs Director

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden Absoluteeldercare Full time

    We are currently working with a Sweden-headquartered medical device business that focuses on biotechnological manufacturing methods and the promotion of cutting-edge and forward-looking biomaterials. Powered by a commitment to change and advancement, they harness their exceptional expertise and distinct capabilities to pioneer new biotechnologies. With...

  • Translator, Medical And Pharmaceutical Translations

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden PharmaLex Full time

    Your Job As part of our Nordic Regulatory Affairs Translation team, your responsibilities will include, but will not be limited to, the following: Translations and reviews of product information texts, promotional materials (medical and pharmaceutical translations), clinical trial documents and a wide variety of other text types for the pharma industry. ...

  • Senior Global Project Manager

    1 month ago

    Gothenburg, Västra Götaland, Sweden Mölnlycke Health Care Full time

    Do you want a career that impacts millions of people for the good? At Mölnlycke, you'll be helping to equip medical professionals with solutions to improve outcomes for patients. And you'll develop your career in a growing organisation with an inspirational culture – where you'll be recognised for the results you've achieved. Mölnlycke is now looking for...

  • Senior Manager Test

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden Northvolt AB Full time

    Senior Manager Test & ValidationAre you an experienced leader, specialized in Li-ion Battery testing and problem solving? Would you like to play a key role in one of Europe's most exciting industrial projects? This is a unique opportunity to be involved early in the development of our organization, building a team and processes for the future. We are...

  • Senior Manager Test

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden NOVO Energy Full time

    Senior Manager Test & ValidationAre you an experienced leader, specialized in Li-ion Battery testing and problem solving? Would you like to play a key role in one of Europe's most exciting industrial projects? This is a unique opportunity to be involved early in the development of our organization, building a team and processes for the future. We are...

  • Samarbetspartner till Quality Management

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden Semcon Full time

    Göteborg Ansök senast: 28 oktober På Semcon bygger vi långsiktiga kundrelationer inom många olika branscher och kompetenser. För att förbättra våra leveranser till kund är vi verksamma som en fullserviceleverantör med samarbetspartners. Just nu söker vi dig som vill arbeta tillsammans med oss inom Quality Management. Som underkonsult till...

  • Manager Laboratory Infrastructure

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden Mölnlycke Full time

    JOIN US AND MAKE A DIFFERENCE Do you want a career that impacts millions of people for the good? Join us at Mölnlycke as we continue our journey to revolutionize care for people and planet. At Mölnlycke, you'll be helping to equip medical professionals with solutions to improve outcomes for patients. And you'll develop your career in a growing...

  • Associate Director, Clinical Regulatory Writing

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...

  • Manager Laboratory Infrastructure

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden Molnlycke Health Care Full time

    Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Create Alert Manager Laboratory Infrastructure & Excellence Gothenburg, SE Ref. number: 7091 JOIN US AND MAKE A DIFFERENCE Do you want a career that impacts millions of people for the good? Join us at Mölnlycke as we continue our journey to revolutionize care...

  • Manager Laboratory Infrastructure

    1 month ago

    Gothenburg, Västra Götaland, Sweden Mölnlycke Health Care Full time

    JOIN US AND MAKE A DIFFERENCEDo you want a career that impacts millions of people for the good? Join us at Mölnlycke as we continue our journey to revolutionize care for people and planet. At Mölnlycke, you'll be helping to equip medical professionals with solutions to improve outcomes for patients. And you'll develop your career in a growing organisation...

  • Samarbetspartner till Quality Management

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden Semcon Full time

    På Semcon bygger vi långsiktiga kundrelationer inom många olika branscher och kompetenser. För att förbättra våra leveranser till kund är vi verksamma som en fullserviceleverantör med samarbetspartners. Just nu söker vi dig som vill arbeta tillsammans med oss inom Quality Management.Som underkonsult till oss på Semcon får du möjlighet att arbeta...

  • Senior Business Analyst, Study Deployment, Evinova

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden AstraZeneca Full time

    Are you ready to be part of the future of healthcare? Can you think big, be bold, and harness the power of digital and AI to tackle longstanding life sciences challenges? Then Evinova, a new health tech business part of the AstraZeneca Group might be for youTransform billions of patients' lives through technology, data, and cutting-edge ways of working....

  • Senior Project Managers

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden Saab AB Full time

    Are you an experienced Project Manager, who wants to take on challenging projects within Surface Sensors Solutions at Saab? Surface Sensors Solutions is growing and we are looking for several Senior Project ManagersYour roleAs a Senior Project Manager at Surface Sensors Solutions you will work as either the main project manager or deputy project manager for...

  • Senior Manager Safety Engineering

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden Northvolt AB Full time

    Senior Manager Safety Engineering & Technical DocumentationWe are building a state-of-the-art Gigafactory that will be one of the largest cell production facilities in Europe. We are now looking for a Senior Manager Safety Engineering & Technical Documentation to join our Engineering teamVolvo Cars is one of the most well-known and respected car brands in...

  • CCRM Nordic Process Development Manager

    3 weeks ago

    Gothenburg, Västra Götaland, Sweden CCRM Nordic AB svb Full time

    CCRM Nordic Process Development Manager & Team LeadLooking for an exciting opportunity to lead a position at CCRM Nordic contributing to Sweden's vision of becoming leader in Advanced Therapy Medicinal Products (ATMPs)?Consider applying for the Process Development Manager & Team Lead role at CCRM Nordic.About CCRM NordicCCRM Nordic is a newly established...