CSV and IT Regulatory Specialist

Why work for Mölnlycke?
As part of Mölnlycke's next level of growth, we are accelerating our value creation, leveraging digitalization with new technologies, data, and a newly created internal IT organization. Looking to deliver increased customer focus, enhanced business collaboration and the adoption of a new DevOps operating model with end-to-end ownership of technology solutions across the organisation. This is a chance to have a real tangible impact within a global business and see how your work directly contributes to the shape of our technological future. You will be empowered to make a true difference, not only for Mölnlycke, but also for patients and health care professionals across the globe.
As part of our technological evolution, we are now looking to further grow the team with the addition of a CSV and IT Regulatory Specialist. The role is a permanent position and a member of an integrated IT Risk, Security, and Compliance Global Team reporting to CISO / IT Director Risk, Security, and Compliance. In this role you will be focusing on IT Regulatory Compliance knowledge in the medical device space and will play a key role in implementing, maintaining and further developing our IT regulatory compliance framework, as well as driving the IT compliance agenda in the global IT organization. We would love to see you placed at our Global HQ in Gothenburg, Sweden but we are open to applications across Europe.


About you:
We are looking for a highly skilled Senior Computerized Systems Validation and IT Regulatory Compliance specialist with a proven track record of IT Regulatory Compliance knowledge and experiences in the context of Medical Device or Pharmaceutical industries.
The role holder is the key point of advisory for IT Regulatory Compliance matters at Global IT. The role holder joins Global IT projects taking the Validation Coordinator role. This is to plan and control Computerized Systems Validation or infrastructure qualification efforts addressing IT regulatory requirements and other IT related authority-based requirements (e.g. FDA Part 11, MDR- SaMD, GDPR,).
Further the position is controlling the compliance of systems, infrastructure settings, IT Processes, and 3rd party suppliers through conducting periodic reviews and audits when needed.
The role holder is updating Global IT Policies, procedures, and working instructions in collaboration with other stakeholders within Mölnlycke, e.g. QA, Legal, R&D to ensure that the Global IT is complaint with all relevant external and internal requirements.
The role holder owns the structure of the CSV repository, together with the training program for CSV.


Key accountabilities for the role:
Improve and maintain the CSV Policy, Procedure, WI, and Forms.
Coordinate CSV efforts in Global Projects assuring that the systems are validated for their intended use – Escalate to SDL and IT Dir. RSC in case of noncompliance.
Conduct Regulatory Risk Assessments and help projects identify regulatory, privacy and other risks, and developing mitigation plans.
Conduct independent Periodic Reviews and audits of IT complaints to regulatory requirements focusing on systems, infrastructure components, 3rd party suppliers, and processes.
Coordinate all internal and external IT Regulatory Compliance related audit efforts when Mölnlycke IT gets audited.
Own and lead all IT related NC efforts from planning towards closer through collaboration with QA and follow ups with relevant NC owners within IT.
Own the structure of the CSV repository tool – assure the availability of CSV evidence there
Own the CSV/IT Compliance training program – Offer training in CSV.
Act as senior validation coordinator for key global systems to help maintaining the validation status of the system(s) through change control efforts.
Lead CSV improvement projects in collaboration with key stakeholders within Mölnlycke, e.g. QA, Legal, R&D, People.
Continually watch the area of IT regulatory compliance and act as Senior SME in CSV / IT Compliance matters.
Collaborate with other relevant IT teams, e.g. Architecture, Security, Service Management to assure that all relevant regulatory requirements on other IT areas are defined and addressed through relevant IT processes and solutions.

If all that sounds appealing, then here is what we would like you to demonstrate:
Senior level experiences (SME) from developing, implementing, and improving IT Regulatory
Compliance related policies, processes, and services
Minimum 5 years of progressive experience in the field of IT Regulatory Compliance and Computerized Systems Validation
M.Sc. in Computer Science / Informatics or other relevant disciplines
Experience in implementing FDA Part 11 is required.
Experiences and knowledge understanding of, GAMP5, or COBIT is seen as meritorious
Given Mölnlyckes industry there are very strict laws and regulations to follow, and we expect the role to have insight and understanding of these as well as the alignment to the relevant Mölnlycke policies


As a person you have a strong drive, can-do mentality, improvement focus and are willing to learn. You are used to work in an international environment, and you have strong interpersonal communication and relation skills. If you enjoy thinking, learning, and collaborating with others to find solutions, gaining commitments and mandate when needed, taking ownership and lead to deliver risk-based IT Regulatory Compliance services in a global environment, you are probably the right person for this position.
The position will entail working globally with different people and you should be able to communicate well in written and spoken English.

About Mölnlycke
Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home proven it every day.

Our approach to diversity and inclusion
We strive to have a diverse mix of people from different cultures, ages, geographies and genders, to reflect the world in which we operate and to facilitate innovative thinking across the business.

If this sounds like you and you feel you have what it takes to succeed in this role, we want to hear from you! Please apply at earliest convenience, we are reviewing candidates continuously.
www.molnlycke.com/career