Ortho Clinical Diagnostics

Quality Regulatory Specialist

Job Locations DE-Neckargemünd
Posted Date 6 days ago(13/3/2018 5:18 PM)
Job Country

The Company

Ortho Clinical Diagnostics (Ortho) is a global leader of in vitro diagnostics.  Ortho serves two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion recipients receive appropriate and compatible blood.


With a history of more than 75 years, Ortho is a pioneer in life-impacting advances in diagnostics. Worldwide across hospitals, hospital networks, blood banks and labs, Ortho’s high-quality products and services enable health care professionals to make better-informed treatment decisions. Headquartered in Raritan, NJ, Ortho Clinical Diagnostics has approximately 4,300 employees serving customers in more than 120 countries.


Ortho is recruiting and retaining the best and brightest around the world. People, who are performance driven, want to make a difference and who help Ortho grow their leadership position in a changing marketplace. The power to reimagine starts with empowered people, who are empowered to grow and given the chance to succeed in ways they hadn’t thought possible before.


Ortho’s purpose is simple: to improve and save lives with diagnostics. They do that by reimagining what’s possible. It’s what defines them. It’s the Ortho difference.


Ortho is an independent company, sponsored by The Carlyle Group, one of the world’s largest and most successful investment firms. The company's executive leadership team has extensive diagnostic experience and a strong heritage of driving market change and innovation. Ortho is a strong brand with solid positions in attractive, growing segments and regions.

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.


Ortho is known in the industry as a leader in customer service and support.  Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do.  It’s who we are.  If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

The Opportunity

As the company continues to grow, we are seeking for Quality Regulatory Specialist to join our team in Germany. 

The Responsibilities

  • Ensure conformity of regulatory processes and strategies to local and international regulations as well as Ortho standards.
  • Contribution to development and implementation of regulatory strategies of the company.
  • Management of communications with regulatory agencies, customers and European Support Center during management of vigilance activities, product notifications, customer complaints and customer communications.
  • Roll-out of field safety corrective actions and field actions in collaboration with global Quality, Regulatory & Compliance functions as well as the product representative/manufacturer.
  • Management of the Quality Management System in alignment with the EMEA Quality strategy, e.g. support of local Management Review, management of Corrective and Preventive Actions as well as support of quality improvement projects.
  • Support of commercial processes, including review and approval of promotional material, QRC support for product lifecycle management and provision of quality and regulatory input to tenders and customer contracts.
  • Support of internal, external and supplier audit program as well as local Health Care Compliance and EHS activities.
  • Regulatory Affairs: Support commercial business through support of Product Lifecycle, completion and maintenance of tender submissions and customer contracts as well as completion of Copy-Review approval of Promotional Material.
  • Roll-out of Field Actions as well as global Customer Communications to authorities and customers, including management of translation of documents into local language. Follow-up on vigilance cases
  • Monitor regulatory requirements and ensure conformity to those. Perform Post-Market Surveillance activities. Complete impact assessment to global Change Control process and complete Product Notifications for new and changed products
  • Act as contact person, liason with local health representative and represent OCD in local regulatory associations
  • Quality: Management and improvement of the Quality Management System in alignment with the EMEA Quality strategy, e.g.conduct Management Reviews, write / maintain quality system documentation and procedures, management of Corrective and Preventive Actions, support global and local Training Program, manage internal audit program as well as identification and sponsorship of  quality improvement projects.
  • Support customer complaint system on local level (e.g. written close-out to customers, iCOM system). Answer to customers quality requests in liason with Hotline.
  • Conduct Audits (internal & supplier). Support external audits.
  • Support of EMEA Health Care Compliance, Privacy and Transparency reporting on interactions with HCPs/HCOs
  • Support local environmental product legislation compliance & safety requirements (e.g. REACH, RoHS; Declaration to local ecobody Waste Electrical and Electronic Equipment (WEEE) and others).

The Individual

  • Technical degree, or diploma in chemistry, biochemistry, biology, pharmacy, engineering or related.
  • Good knowledge in ISO stanadards
  • Good knowledge in IVD Medical device environment
  • At least 3 years of experiences in a similar position in regulated industry (Medical Device, IVD or drugs). 
  • Independent working ability.
  • Good knowledge of the IVD Medical Device regulatory environment. 
  • Experience in managing Quality Systems (ISO 9001 standards).
  • Fluent in German English (oral and written). Advanced language skills in at least one other language desired (depending on target market to be covered)


Equal Opportunity

At Ortho Clinical Diagnostics, we are proud of the empowering, inclusive and innovative culture we are growing. Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making Ortho a place to grow your career. 


Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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