Diagnostica is a well-established Oslo-based MedTech company that develops and sells diagnostic software for primary and occupational healthcare. Our product Spirare supports examinations within spirometry, ECG and 24-hour blood pressure measurement. Our products are used by doctors and healthcare personnel in both Norway and Sweden. We are certified according to ISO13485, and are currently working to get Spirare approved according to MDR, the EU’s Medical Device Regulation.
QA Manager – for RA- Regulatory Affairs
It is a central leadership role, and your efforts will be decisive for the company’s further development. We hope you will be part of a competent and dedicated team.
Utvikle og vedlikeholde Fagskolen kvalitetssystemer
1. Head of QA and regulatory affairs (RA – Regulatory Affairs)
Lead the company’s QA work and ensure that the work in the company takes place within the framework set by the quality system. See Appendix 1: Job Description QA / RA
2. Document manager
Ensure that the documents covered by the quality system are managed according to regulations. Ensure that the company has the necessary tools so that document management can take place efficiently and correctly.
3. Responsible for testing the company’s software
Administer testing of the company’s products, and ensure that this takes place according to the quality system and any other regulatory requirements. If necessary, participate in the practical implementation of the tests.
Skills – our new colleague can respond to the following:
- Excellent interpersonal and communication skills.
- Adherence to timelines.
- Good understanding of medical devices regulatory environment (MDR).
- Good knowledge of medical devices quality assurance (ISO 13485) and relevant standards.
- Good technical overview of medical device verification and validation testing.
- Excellent English skills, oral and written.
- Relevant experience in Quality Management or Regulatory Affairs in Medical Device Industry.
- Experience with QMS Audits by authorities / notified bodies.
Job Description QA / RA
- QA/RA is responsible for all activities related to the QMS, Quality Control and Regulatory Affairs.
- QA/RA represents the company to Notified Bodies, regulatory authorities as well as customers, distributors and suppliers.
- QA/RA is responsible for overseeing the development and maintenance of quality systems as well as coordinating regulatory activities for Diagnostica. The role holds a position that necessitates a thorough understanding of key aspects of both disciplines Quality Assurance and Regulatory Affairs.
- Preparing reports.
- Complying with quality policy and quality objectives.
- Complies with federal, state, and local legal requirements by studying existing and new legislation, enforcing adherence to requirements, and advising management on needed actions.
- Management Representative (MR).
- Person Responsible for Regulatory Compliance (PRRC).
- Contact Person for Notified Body and Competent Authorities.
- Organizing and performing internal and external Audits and monitoring the Implementation of Audit results.
- Keeping the Diagnostica Quality Management System current and compliant by developing, revising, and implementing Quality procedures and policies for Diagnostica to facilitate relevant company certifications and Regulatory compliance.
- Maintaining an up-to-date awareness of relevant legislation which may impact the QMS and communicate this effectively.
- Promoting the benefits of the quality system to all employees.
- Administering, preparing and conducting internal QMS audits and external supplier assurance audits as necessary.
- Master’s Degree or equivalent in Life Science or equivalent post degree qualification.
- Strong knowledge of current versions of ISO 13485 and ISO 14971.
- Strong knowledge and understanding of medical devices regulatory environment (93/42/EU MDD, EU 2017/745 MDR and FDA QSR).
- Auditor / Lead Auditor for ISO 13485 is an advantage.