Regulatory Affairs Specialist

Arjo; Poznań; On-site; PLN 70,000 - 100,000; Full time

Job summary

ArjoHuntleigh Polska sp. z o.o. is seeking a Regulatory Affairs Specialist to join the Malmo global QRC Product Registrations team, based in Komorniki near Poznań, Poland.

You will plan and execute regulatory strategies for timely registration of Arjo and OEM products, ensuring compliance with global and local regulations. The role involves preparing submissions for Class I, Im, IIa devices, coordinating with internal teams, and maintaining up-to-date regulatory knowledge.

Qualifications

• BA or BS degree with a major in a scientific discipline.
• Regulatory experience in medical devices or QA desirable.
• Ability to write licence applications in English clearly and accurately.
• Ability to render clear, well-reasoned judgments and make decisions.

Responsibilities

• 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.
• 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 and guidelines within area of responsibility.
• Assist in projects within Regulatory Affairs; act as internal auditor to processes and external standards.

Skills

Excellent communication

Cross-functional teamwork

Independent work

Attention to detail

Analytical thinking

Problem solving

Education

BA or BS in science

Job description

Position: Regulatory Affairs Specialist Location: Komorniki (near Poznań)

Job Type: Full time

Company: ArjoHuntleigh Polska sp. z o.o.

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.

Key duties include

• 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 regulations
• Curiosity: 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.

Please be aware that by applying for this role you are giving Arjo permission to store your information.