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Arbeidsgiver
Dignio AS
Stillingstittel
Compliance Manager
Frist
Snarest
Ansettelsesform
Fast
As a provider of a software platform with associated hardware which are CE marked as medical devices, we have implemented a Quality Management System which is certified against ISO 13485 and ISO 27001. A strong internal compliance team is therefore a high priority. The legal and compliance team supports the company in making informed decisions based on principles of commercial opportunity and risk management as well as maintaining the company’s governance and compliance.
We are now looking for a new colleague, with minimum three years’ work experience, to join our team. You should have a holistic and pragmatic understanding of the regulatory framework governing Medical Devices, privacy and information security and thrive in a fast-paced international environment that encourages diversity in culture, skills, and knowledge.
The Compliance Officer is responsible for the implementation and management of the Quality Management System, the preparation and on time regulatory filings and preparing responses to questions from regulatory agencies. In addition, the role is responsible for reviewing the portfolio of products to ensure proper management from a regulatory perspective. The role will work closely with the Product and Technology teams on new product development, necessary regulatory activities required for product market entry, and in-market device management.
Main tasks
- Manage all aspects of the Dignio’s Quality Management System, including policy and process development pursuant to regulatory requirements relevant for Medical Devices
- Ensure all products, including software, hardware, electronics, apps, and IT hardware comply with applicable EU and US Regulations
- Work closely with product development stakeholders by preparing regulatory assessments and plans for regulatory compliance
- Author documentation and regulatory filings and prepare responses to questions from the regulatory agencies
- Work closely with Support and Quality teams on complaints, recalls and mandatory reporting
- Review labeling, marketing literature, and user manuals to ensure regulatory compliance
- Work with the tech and legal teams to ensure that the company and its products comply with applicable information security regulations (e.g. GDPR, HIPAA, ISO 27001)
- Conduct internal risk assessments and assist in the management of external risk management processes
- Conduct internal audits pursuant to relevant standards
- Manage external audits conducted by notified bodies (e.g. relating to Medical Devices Regulation, ISO 13485, ISO 27001 etc).
- Conduct supplier and product validations
- Assist in drafting tender responses within the area of medical device regulatory and information security
- Assist with market entry into new jurisdictions
- Support the business and support functions in the day-to-day interpretation of compliance matters
Requirements
- Bachelor’s degree in Engineering, Science or related discipline
- Post-graduate diploma/certification in Compliance/Regulatory Affairs is an asset.
- 3-5 years of experience working on international regulations for Medical Devices, privacy, information security and associated regulations in the EU
- Working experience with regulations for Medical Devices, privacy and information security and associated regulations in the US and/or Canada is an asset
- 3-5 years of working regulatory experience in a software and/or electrical/electronic Medical Device environment
- Experience implementing and managing a Quality Management System
- Knowledge and experience working with international standards applicable for Medical Devices and its components (ISO 13485, ISO 14971, IEC 62304, IEC 60601 etc.)
- Experience interfacing with Regulatory Agencies
- Knowledge in Project Management and Quality Assurance is an asset
- Knowledge of applicable information security regulations (GDPR, HIPAA, ISO 27001)
- Full professional fluency in Norwegian and English language, oral and written.
- Technically skilled and used to working with digital tools
Personal qualities
- Structured, development oriented and high degree of flexiibility
- Strong written and oral communication skills, with the ability to present complex ideas in a simple manner
- Autonomous with a strong ability to self motivate
- High integrity and problem-solving skills, with a "can do” attitude
- Pragmatic and taking risk based approaches
- Strong attention to detail with the ability to multitask and meet deadlines in a timely manner
- Excellent analytical, organizational, and problem-solving skills
- Proven ability to adhere to standards/procedures and maintain confidentiality
- Able to effectively work with other teams to achieve objectives
- Ability to build good relationships, cooperate and communicate
- Networking with peer professionals in other organizations
- Motivated/driven by Dignio’s impact agenda, which is to help patients live healthier and better lives
- Being excited about shaping the future of healthcare
We offer
- An opportunity to become a key employee in a company with the ambition to change healthcare for patients and healthcare professionals all over the world
- A young, diverse and ambitious culture with a real passion for their work
- An opportunity to work in an interdisciplinary team consisting of medical doctors, nurses, software engineers, designers, finance professionals etc.
- Flat hierarchy where your voice will matter
- Competitive salary and the possibility to buy shares in the company.
- Flexibility in working hours and location
- Best-in-class company health and travel insurance
- New, modern offices in central Oslo
Om arbeidsgiveren
Dignio is a market-leading company for development and delivery of Connected Care systems. Our technology combines hardware and software with clinical methodology to bring healthcare to the patient’s home. With our solution healthcare personnel can follow up patients in a safe way, and at the same time give patients both flexibility and a sense of achievement. The results are improved patient outcomes, energised clinical staff, and higher efficiency in the healthcare system.
Sektor
Privat
Sted
Stenersgata 1A, 0050 Oslo
Bransje
Helse og omsorg,
Juridiske tjenester,
Konsulent og rådgivning
Stillingsfunksjon
Jurist,
Konsulent,
Kvalitetssikring
Nøkkelord
compliance, legal, information security, governance, regulatory
