Position: Regulatory Clinical Affairs Specialist
Location: Malmö
Job type: Full time, Permanent
The impact you will have
By joining Regulatory Affairs at Arjo, you will be a central part of a team that develop and matain clinical evaluation documentation according to MDR. In this role you are the clinical partner in different R&D projects, vigilance activites and responsible to supply clinical responses for our Notified body or other Agencies.
As the R... Visa mer
Position: Regulatory Clinical Affairs Specialist
Location: Malmö
Job type: Full time, Permanent
The impact you will have
By joining Regulatory Affairs at Arjo, you will be a central part of a team that develop and matain clinical evaluation documentation according to MDR. In this role you are the clinical partner in different R&D projects, vigilance activites and responsible to supply clinical responses for our Notified body or other Agencies.
As the Regulatory Clinical Affairs Specialist you will be responsible for:
Clinical Evaluation
• Develop clinical evaluation reports (CERs) and post-market clinical follow-up (PMCF) reports, as well as summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards and business needs.
• Compile, appraise, and evaluate data from multiple sources including clinical trials, medical literature, design verification/validation data, and product complaint data. Includes development of literature search strategies and methodical evaluation of medical literature.
• Create analyses to evaluate product benefit/risk profile and safety and performance and develop profile of adverse events. Identify potential clinical evidence gaps and contribute to development of prospective evidence strategies to address gaps.
• Ensure alignment of clinical data with product risk documentation, product labeling incl. IFUs and marketing materials.
Clinical Support
• Provides clinical input to product development and post-market sustaining teams.
• Participate in projects as clinical support.
• Aid in the development of regulatory responses for regulatory submissions
• Maintain and develop efficient clinical evaluation procedures.
Quality System Duties and Responsibilities
• Clinical SME in Health Hazard Evaluations and Product Risk Assessments
• Maintain and develop efficient clinical evaluation procedures.
The skills you will need
• Masters degree in scientific or medical discipline with familiarity in clinical evaluation report writing in the medical device industry or in scientific writing
• Knowledge and experience with MDR, MEDDEV 2.7.1 Rev 4 Clinical Evaluations, and MEDDEV 2.12-2 PMCF
• Experience and skill performing systematic medical/ scientific literature searches (PubMed, Google Scholar, etc.)
• Knowledge of research methodology (including clinical investigation design and biostatistics) preferred
• Excellent written and oral communications skills- strong attention to detail related to consistency, grammar, syntax, and accuracy
• Demonstrated ability to work in a team environment, including leading discussions and presenting to internal business and regulatory stakeholders
• Ability to identify and mitigate or escalate risks; identify roles/individuals to involve for decision making within clinical evaluation assessment and report development
• Project/timeline management skills and organizational skills
• Ability to prioritize and manage multiple projects and adapt to change as needed
• Self-starter attitude with ability to learn quickly and self-educate on different medical device products and procedures; ability to work independently with minimal supervision
• Strong familiarity with Microsoft Office and Endnote
• Bio-engineering, Medical licensing or healthcare experience preferred .
• Knowledge and experience with ISO14971 Risk Management is a plus
Personal Qualities:
• Engagement
• Self driven
• Team player
What we will offer in return
You will be part of a high performing and helpful team. You will support our vision to be the most trusted partner in driving healthier outcomes for people facing mobility challenges. In return, we recognize and value our global employees. You will have our full support, training and opportunities for professional development.
At Arjo, we believe in embracing flexible ways of working. This may include remote working, in-office working or homeworking. As the role of the physical office will remain important in enabling collaboration, creativity, social interaction, and in building and fostering the Arjo culture, we believe in a hybrid approach with a mix of in-office and remote working. This role is based at Arjos HQ in Malmö with a modern office space and walking distance to Malmö central station.
In Arjo, we actively develop our people in several ways. Our Talent Programs allow employees to share knowledge and work together on strategic business projects, under the guidance of the Arjo Management Team. Through our Mentorship Program, we prepare our employees for career advancement within the organisation, while enhancing skills in key areas. With our assessment tools we support high performing teams and help employees stay in tune with what motivates them. Our global Academy offers speclialised product, clinical and customer related training.
Why diversity matters to us
At Arjo, we believe in the power of diversity. We strongly encourage applicants from all parts of society, which means building a more diverse, equitable, inclusive and engaging environment – not only in the workplace, but also within the communities that we serve, work in and live in. We achieve this through a culture and mindset that values the uniqueness of all our people.
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