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Regulatory Affairs specialist- IVD/MD

Job Description


Are you an individual with knowledge in IVD or Medical Devices, looking for a new challenge in your career? A job where your actions will have an impact improving quality of life. Then we are looking for you!

Come and join us in a highly collaborative environment where we fight cancer together! You will be part of our two most profitable divisions, Pathology' and 'Reagent Partnerships and be exposed to innovative IVD products across different regulatory classifications including hardware, software and immunochemistry technologies.

We are searching for an upbeat and driven Regulatory Specialist to play a key role in implementing Regulatory QMS procedures in compliance with the EU IVDR, and help to acquire NB certification for our extensive IVD portfolio.

In order to succeed  the successful candidate will have proven capability in: analytical and critical thinking; collaborating with cross functional teams; driving results.  This includes but not limited;

  • Development and implementation of regulatory procedures to comply with the EU IVD regulation.
  • Ensuring sufficiency of our technical documentation and NB certification of IVD products for cancer diagnostics.
  • Compilation of STED files for regulatory submissions required for IVDR certification and new country registrations.
  • Working in new product development projects, managing strategies, submissions, license renewals and annual registrations.
  • Maintain and update information about global regulatory requirements.
  • Reviewing product labelling and marketing materials for regulatory compliance.
  • Representing the company towards notified body and authorities at the global level, responding to requests/inquiries about regulations and product compliance.
  • About the Company

    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 seek -- so they can do what they do best: improve the world around us. .


    Qualifications


  • A degree in a relevant field (including, but not limited to: biochemistry/engineer/law), combined with regulatory experience. If, additionally, you hold a certification in a specialised relevant area, that is considered a plus.
  • Good knowledge and proven experience of EU MDR and/or IVD Regulation
  • Ability to interpret regulations and standards in relation to specific products.
  • Understanding of design controls and in depth knowledge of applicable standards (ISO 13485, 14971, 62366, 23640, etc.)
  • Experience with audits from regulatory authorities and EU notified bodies.
  • Soft Attributes

  • Self-driven with the aptitude to work independently and in a team to execute goals in a timely fashion.
  • A positive and energetic professional who can work under pressure and balance projects.
  • Good interpersonal and communication skills in Danish and English
  • We offer:

  • An independent job in collaboration with good colleagues, in a growth orientated organization.
  • Career and training opportunities in a compassionate and demanding corporate environment, with a culture built on principles of trust, respect and teamwork, and steadfast integrity.
  • A true commitment to work/life balance.
  • Questions

    If you have questions about this position and the application process please contact the recruiter, Sandra Anyanwu on sandra.anyanwu@non.agilent.com.

    Agilent Technologies Inc. is an equal opportunity employer and value diversity at our company. Qualified applicants will receive consideration for employment without regard to race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, disability status or any other protected categories under all applicable laws.



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