18/02/2021
Holberg EEG AS is developing medical devices and expanding into new geographical markets, and the Manager – Clinical & Regulatory will work together with the Manager QA/RA to ensure that regulatory requirements for the product and the QMS are met. They will provide the required regulatory input for development of the medical device as well as serve as person responsible for regulatory compliance of our products.
The Clinical & Regulatory Manager is responsible for understanding and fulfilling the company’s values, strategies and organizational guidelines. You will join a dynamic and fast-paced environment and be part of an international team. Reports to the QA/RA Manager.
Key Responsibilities
1. Ensure that regulatory requirements for the medical device for US, EU and Canada are met in the QMS.
2. Ensure that regulatory requirements are translated into technical requirements for product development.
3. Plan & Manage the clinical evaluation of SaMD developed by HOLBERG EEG.
4. Plan & Manage the technical documentation as required by EU, US and provide support to expand to further geographical areas.
5. Ensure appropriate Post Market Surveillance of the products and take necessary actions.
6. Conduct Risk Management activities.
7. Support ISO & US FDA Audits.
8. Act as person responsible for regulatory compliance (PRRC) under the MDR.
Other Responsibilities
1. Perform Internal Audits as required
2. Perform Supplier Audits as required
3. Provide key input to maintain an effective Quality Management System for ISO 13485 & ISO 27001
4. Participate in the Product Development Life Cycle - Design Reviews
The minimum requirements for successfully perform the job is:
• BS/MSc in applicable engineering discipline or equivalent experience in a medical device environment (5+ years’ experience is preferred).
• Documented knowledge/experience within medical quality and regulatory assurance. Have prior experience managing and writing technical documentations for EU MDR and US FDA.
• Prior experience in managing Clinical Evaluations & Investigations and ensure that this documentation is of top quality.
• Experience in setting up quality management systems and company procedures from scratch and performing internal and external audits as well as managing on-site regulatory bodies’ audits/inspections is an advantage.
• Good understanding of design controls, including IEC 62304 (medical device software life-cycle processes), and post-market surveillance.
• Good working knowledge of the CE marking process & 510K clearance is a requirement.
• Understanding of software development regimes and software products is a requirement. Prior experience in working with Agile development methodology is a must.
• Experience in data/patient integrity regulation is a plus (such as GDPR and HIPAA in the US).
• Experience of launching and managing medical software or medical device products on international markets.
• Diligent, but the same time pragmatic and business minded.
• Understand how to use quality as a competitive advantage.
• Able to lead, engage and motivate teams to drive the necessary changes as well as interact on several levels in the company. Experience from teaching or leading training or education is a plus.
Working Conditions
Holberg EEG have employees working from Norway, India, the Netherlands, and the UK. Main office is located in Bergen, Norway. Employees in Bergen will be working with the rest of the team in the company office. There’s also an office based in Hyderabad, India. Holberg EEG’s employees in the UK and the Netherlands work full remote home based. We currently only invite applicants from Norway, India, UK and the Netherlands. Very minimal travel could be required.
The evaluation of the position will be made based on:
• Ability to comply with the Company’s values.
• Achievement of goals and objectives.
• Initiative and quality of work.
