Regulatory Affairs Specialist

Kelly Science, Engineering, Technology & Telecom; Polska; In loco; PLN 90.000 - 135.000; Tempo pieno

Descrizione del lavoro

Kelly Science, Engineering, Technology & Telecom in Poland is seeking a Regulatory Affairs Documentation Specialist to support a global medical technology program. You will manage regulatory documentation, labeling materials and submission publishing within an international team.

The role emphasizes accuracy, organised processes, and collaboration across regions, with a 12-month fixed-term contract under an outsourced service model.

Competenze

• Experience in regulatory documentation lifecycle.
• Familiarity with MDR and EU medical device regulations.
• Excellent attention to detail and organisational skills.

Mansioni

• Prepare, coordinate, dispatch and file routine regulatory documentation.
• Coordinate submissions and labeling activities.
• Publish and manage documents in electronic systems and ensure records are current.
• Support regulatory tracking, metrics and reporting to enable operations insight.

Conoscenze

Regulatory documentation

Document control

Quality systems

Regulatory submissions

Word/Excel proficiency

Strumenti

QUMAS

Agile

MDRIM

Descrizione del lavoro

Regulatory Affairs Documentation Specialist

Kelly Science, Engineering, Technology & Telecom | Poland

Contract: 12-month fixed-term contract, with the possibility of extension

Employment model: Full-time, via Kelly's outsourced service provider (FSP) model

Start date: December ideally

About the Opportunity:

Kelly is seeking a detail-oriented Regulatory Affairs Documentation Specialist to support a global medical technology organisation operating at the forefront of healthcare innovation. This is an excellent opportunity to contribute to regulatory operations within an international MedTech environment, supporting the documentation, publishing, tracking and maintenance activities required to bring medical technologies to market and maintain their regulatory compliance across multiple regions.

Working closely with Regulatory Affairs teams and cross-functional stakeholders, you will help ensure that regulatory submissions, product labelling and associated documentation are accurate, consistent, appropriately formatted and managed in accordance with applicable regulatory requirements and internal quality standards.

The position combines regulatory documentation, electronic document management, submission coordination and process improvement. It would suit someone who enjoys working in a structured, quality-driven environment and is comfortable managing multiple documentation activities, deadlines and stakeholders across an international organisation.

About the Organisation:

Our client is a globally recognised medical technology business operating across several major healthcare markets. The organisation develops and delivers technologies, medical devices and solutions designed to improve patient outcomes, support healthcare professionals and address complex clinical needs.

With an established international presence and a broad portfolio of healthcare technologies, the business operates within a highly regulated industry where product safety, quality, regulatory compliance and reliable documentation are essential. Its products and services support healthcare professionals and healthcare systems in delivering effective treatment and care to patients worldwide.

The organisation works across global and regional teams, bringing together regulatory, quality, engineering, clinical and commercial expertise to support product development, market access and ongoing product lifecycle management.

The Role:

As a Regulatory Affairs Documentation Specialist, you will provide operational and administrative support to global and regional Regulatory Affairs activities. Your primary responsibility will be to ensure that regulatory documentation and labelling-related materials are prepared, finalised, published, tracked and maintained to the required standards.

You will collaborate with Regulatory Affairs colleagues to prioritise incoming activities, coordinate routine submissions, maintain accurate documentation records and support consistency across regional processes. You will also contribute to the maintenance of regulatory strategies, approval trackers and reporting tools, helping teams monitor submission progress, market approvals and relevant regulatory milestones.

This role requires strong attention to detail, organisational skills and the ability to manage documentation in a controlled, regulated environment.

Key Responsibilities:

Regulatory Documentation and Submission Support

• Prepare, coordinate, dispatch and file routine Regulatory Affairs documentation in accordance with established processes and applicable requirements.
• Collaborate with Regulatory Affairs colleagues to prioritise, triage and coordinate routine regulatory submissions and labelling activities.
• Finalise regulatory submissions and labelling documentation through editing, formatting and quality checks, ensuring compliance with current regulatory guidelines, internal procedures and document standards.
• Compile, organise and maintain the documentation required to support regulatory submissions and product-related activities.
• Coordinate the legalisation and apostille of regulatory documents required for Health Authority submissions, where applicable.
• Support other global Regulatory Affairs administrative activities as required.

Document Publishing and Electronic Document Management

• Publish, archive and upload regulatory documentation to electronic document management systems and other designated tools.
• Collect, import, edit and create documents within electronic documentation storage and retrieval systems.
• Establish, organise and maintain electronic filing structures for regional regulatory submissions and labelling documentation.
• Support document migration, maintenance and retrieval to ensure regulatory records remain organised, accessible and current.
• Prepare, maintain and update document templates, ensuring consistency with company formatting and design standards.
• Perform operational document management activities, including scanning, printing, filing and maintaining submission components.
• Route documentation through relevant Quality Management Systems, such as QUMAS or Agile, where required.
• Assist with training materials and user training relating to electronic documentation systems and regulatory document preparation.

Regulatory Strategy and Product Approval Tracking

• Create, manage and maintain regulatory strategies within the designated regulatory management system (MDRIM) for new products, post-market changes and related regulatory activities.
• Follow up with regional teams to ensure required information and responses are provided in a timely manner.
• Maintain trackers covering regulatory strategies, applicable dates, submission milestones and market approval status.
• Monitor approval status across impacted markets and ensure tracking information is accurate and up to date.
• Process and track product release forms associated with product approvals, including post-approval labelling activities.
• Compile, maintain and report submission-related metrics to support operational visibility and performance monitoring.

Process Consistency and Continuous Improvement

• Support consistent documentation practices, templates and standards across the assigned region.
• Collaborate with colleagues in other regions to promote alignment and consistency in regulatory documentation processes.
• Identify opportunities to improve document management, tracking, reporting and administrative workflows.
• Help ensure that regulatory records are maintained in line with established procedures, documentation standards and quality requirements.

Candidate Requirements:

We are looking for a highly organised and detail-focused professional who can manage regulatory documentation accurately while working collaboratively with international teams.

Essential or highly relevant experience:

• Previous experience in Regulatory Affairs, regulatory documentation, document control, quality systems or a similar regulated administrative function.
• Experience preparing, editing, formatting, reviewing or maintaining controlled documentation.
• Familiarity with electronic document management systems, regulatory information systems or Quality Management Systems.
• Strong organisational skills, with the ability to manage multiple activities, maintain trackers and meet deadlines.
• Excellent attention to detail and a commitment to documentation accuracy, consistency and compliance.
• Strong written communication skills and the ability to collaborate with stakeholders across functions and regions.
• Good working knowledge of Microsoft Office applications, particularly Word and Excel.
• A proactive, structured approach to problem-solving, follow-up and process improvement.
• Previous experience within the medical device or wider MedTech industry.
• Exposure to regulatory submissions, product labelling, market approvals or post-market regulatory changes.
• Familiarity with medical device regulatory frameworks, including the EU Medical Device Regulation (MDR).
• Experience with systems such as QUMAS, Agile or MDRIM, or comparable regulatory and quality management platforms.
• Experience supporting global or regional Regulatory Affairs teams in an international organisation.
• Knowledge of document publishing, submission tracking, regulatory metrics or document lifecycle management.

Key Skills and Competencies

• Regulatory documentation and submission coordination
• Document control and electronic document management
• Quality systems and controlled documentation
• Regulatory strategy and approval tracking
• Product labelling and post-approval documentation
• Data accuracy, reporting and submission metrics
• Stakeholder coordination across regional and global teams
• Process consistency and continuous improvement
• Organisation, prioritisation and deadline management
• Attention to detail and compliance-focused working practices

What the Opportunity Offers

• The opportunity to work within a globally established medical technology organisation.
• Exposure to international Regulatory Affairs operations and product lifecycle activities.
• Experience supporting regulatory documentation and approvals across multiple markets.
• Collaboration with experienced regulatory and quality professionals.
• An initial 12-month fixed-term contract, with the possibility of extension depending on project requirements and business needs.
• Employment through Kelly's outsourced service provider (FSP) model, supporting a major healthcare organisation.