Regulatory Affairs Specialist

Arjo Italia S.p.A.; gmina Komorniki; Sur place; PLN 120 000 - 180 000; Plein temps

Résumé du poste

Arjo is seeking a Regulatory Affairs Specialist to join the Malmo global QRC Product Registrations team, based in Komorniki, near Poznan, Poland. The role focuses on planning regulatory strategies and executing registrations for Arjo and OEM product portfolios while ensuring compliance with international and local requirements.

You will prepare submissions for medical device licences, coordinate with engineering and QA teams, and maintain up-to-date knowledge of regulatory changes to support

Qualifications

• Regulatory experience in medical devices or QA environment preferred.
• Clear, concise English licensing documents and regulatory submissions.
• Ability to work in cross-functional teams and communicate effectively.

Responsabilités

• Prepare regulatory submissions for new and amended licences for Class I, Im, and IIa devices.
• Communicate progress with internal stakeholders: project owners, engineering, publications, SSUs, and management.
• Liaise with affiliates, distributors and authorities to secure timely licence approvals.

Connaissances

Regulatory experience

English writing

Cross-functional teamwork

Independent work

Communication skills

Scientific background

Formation

Bachelor's degree in a scientific discipline

Description du poste

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Empowering careers at ARJO

At Arjo, we know what moves us. We go above and beyond for people facing mobility challenges. We take every opportunity to work and grow as one team and take pride in sharing our knowledge and experience. Does that sound like something that moves you too?

This could be your opportunity to begin a challenging and rewarding career in a healthcare company that empowers movement for people with mobility challenges.

The Role

An exciting opportunity for a Regulatory Affairs Specialist to join the Malmo global QRC Product Registrations team, based in based in Komorniki, near Poznan, Poland. The role will be responsible for conducting international product registrations for all Arjo and OEM product portfolios and also supporting wider QRC projects and activities . Focus of the role will be to plan and execute regulatory strategies for the timely registration and approval of our products and also to ensure compliance with global and local country regulations and requirements.

• Prepares regulatory submissions for new and amended product licence applications for Class I, Im, and IIa medical devices.
• Communicate progress of registrations with internal stakeholders: Project Owners, Engineering, Technical Publications, SSUs, Commercial and Management as required.
• Liaise with international affiliates, SSUs, distributors and competent authorities to ensure timely licence approvals.
• Records registration activities on internal tracking databases.
• Prepare briefing summaries and training on regulations, processes and guidelines within area of responsibility.
• Assist in projects within the Regulatory Affairs function.
• Act as an internal auditor to established processes and external standards and regulations
• Ensure and maintain up to date knowledge on international regulatory requirements within assigned scope, and effectively communicate requirements to project teams and management.

Knowledge/Skills/Experience:

• BA or BS degree with a major in a scientific discipline
• Regulatory experience in the medical device industry or experience in Quality Assurance or similar desirable
• Must be able to synthesise technical and clinical information to write clear, understandable licence application documents in EnglishMust be able to render clear and accurate judgments and have decision making skills.
• Ability to work well in cross-functional teams
• Excellent written and verbal communication skills
• Ability to work independently in a well-structured and systematic manner

Personal Qualities:

• Attention to Detail: Regulatory affairs specialists must meticulously review documents and ensure compliance with regulationsCuriosity: Questioning interest around the regulatory industry, the whole product lifecycle and our QMS processes, is a valuable quality
• Analytical Thinking: They need to analyse complex regulations and apply them to specific situations
• Communication Skills: Effective communication with regulatory bodies and internal teams is crucial
• Problem-Solving: They must be adept at identifying issues and finding compliant solutions
• Conscientiousness: Being thorough and diligent in their work is essential
• Adaptability: The regulatory landscape can change frequently, so being adaptable is important
• Working well with cross-functional teams is often necessary to ensure compliance
• Commitment to Continuous Learning: Staying updated with the latest regulations and guidelines

A career in Regulatory and Quality Compliance will give you plenty of professional challenges. You will become part of close-knit team supporting many important areas of the Arjo business.

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About Arjo

At Arjo, we believe that empowering movement within healthcare environments is essential to quality care. Our products and solutions are designed to promote a safe and dignified experience through patient handling, medical beds, personal hygiene, disinfection, diagnostics, and the prevention of pressure injuries and venous thromboembolism. With over 6500 people worldwide and 65 years caring for patients and healthcare professionals, we are committed to driving healthier outcomes for people facing mobility challenges.