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Location: Europe (remote)

Contract: 12 months with possible extension

VGS a Kelly Company is seeking a Russian Speaking Regulatory Affairs Specialist to work with a top medical devices client, focusing on surgical devices. This role offers the opportunity to lead regulatory efforts and ensure compliance in product modifications and strategic planning.

Key Responsibilities

• Prepare regulatory registration documents and notifications for the surgical devices
• Provide regulatory support for product changes and modifications.
• Support strategic planning and portfolio management in the regulatory domain
• Guide local business partners and liaise with the Regulatory Affairs teams
• Interact with local distributors for portfolio modifications.
• Ensure compliance with regulatory agency standards and interpretations.
• Prepare responses to inquiries from regulatory agencies.
• Generate necessary deliverables, including outlines, summaries, status reports, and visual presentations.
• Provide solutions to issues of moderate complexity.
• Conduct searches of existing files for requested information.
• Maintain and archive all regulatory documentation.

Education and Experience Requirements

• A Bachelor's degree in a technical-related field is required; a Master’s degree is advantageous.
• 2-5 years of experience in Regulatory Affairs or equivalent experience.
• Full familiarity with the local Russian RA requirements.
• Experience registering medical devices with local authorities is required.
• Ability to work independently and within a team.
• Problem-solving skills and the ability to identify solutions for the process gap.
• Experience with surgical devices is an advantage
• Familiarity with the Russian Federation portal, Gosuslugi.

Opportunities

• Work with innovative projects in surgical device technology that influence the future of healthcare
• Participate in a role with potential professional growth
• Opportunity to work with a leading MedTech company

Company Culture

Join a dynamic team at VGS a Kelly Company where innovation, integrity, and collaboration are key values. Help shape the future of surgical devices with impactful solutions and a supportive team environment.

Contract: 18 months

Location: Galway, Ireland

VGS a Kelly Company is looking for a Design Quality Engineer to join the team. The role will report into the Staff Quality Engineer and involves working closely with the project to ensure its successful completion. It is important to note that this is a catheter-based project, not a chemistry-based one. The position is critical to the final stages of the project, and there may be an opportunity for ongoing involvement following the project.

JOB RESPOSIBILITIES:

• Ensure compliance with Design Control and Risk Management activities and processes, managing and completing Quality deliverables for R&D projects.
• Provide Quality support and guidance to R&D project leads and team members, and direct Design Quality Engineers and Quality Engineers.
• Resolve project issues through collaboration with team members, suppliers, and other stakeholders, applying systematic problem-solving methodologies.
• Manage and maintain records related to design control projects, participate in design review meetings, and generate risk management file documents.
• Develop and review protocols and reports for sterilization, biocompatibility, and packaging validations, as well as review and approve R&D batch details and production records.
• Monitor data from Quality Management systems, provide immediate feedback on deviations or issues, and lead or facilitate compliance and improvement activities (e.g., CAPA/non-conformance).

Must have

• 5 years of experience in a similar role
• Experience within Quality Assurance for medical devices in R&D including Validation, Design and Risk Management
• Experience in managing their own projects independently
• Independent and accountable, able to work on project, efficient communication
• Available to work from Galway, flexible to go on site for urgency

If this sounds exciting don't hesitate to apply today!

Location: EU (preferably Switzerland)

Contract: 12 months with possible extension

Exciting opportunity for a Clinical Research Scientist (MDR) to develop post-market clinical research strategies for orthopedic devices and make a meaningful impact in the field. Collaborate with cross-functional teams to align with EU Medical Device Regulations and maintain a strong understanding of evolving post-market evidence requirements.

Role Overview

The Clinical Research Scientist (MDR) will be responsible for the development of post-market clinical research strategies for orthopedic devices to support global regulatory and post-market surveillance requirements.

Responsibilities include:

• Work closely with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to develop post-market clinical evidence generation strategies that consider evidence needs for EU Medical Device Regulations (EU MDR). Facilitate clinical evidence reviews with a cross-functional team to align on clinical evidence strategies, document/track decisions and risks, and write PMCF Plans. 
• Develop and write high-quality Post-market Clinical Follow-up (PMCF) plans and reports with minimal supervision. Support development and drafting of clinical study protocols, registry plans, epidemiology studies, informed consent, investigator brochures, and other study materials where needed. 
• Review summaries of clinical evidence and PMCF strategies in other areas of the Technical Documentation for accuracy and completeness. This includes the Clinical Evaluation Plan, Clinical Evaluation Report (CEP), Post Market Surveillance Plan and Periodic Safety Update Report (PSUR).
• Maintain a strong understanding of evolving post-market evidence requirements under the EU Medical Device Regulation. 
• Where required, foster relationships with surgeons, hospitals and research teams to gain input into study design, evaluate study feasibility, and identify sites for study execution or data collection. Develop strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders.
• Partner with the Contracts and Payments team to ensure timely execution of all study agreements and corresponding payments for achieved milestones and deliverables.
• Support clinical scientific discussions with internal stakeholders within Clinical, Medical, Regulatory, R&D and Marketing to drive support of the clinical and regulatory strategy, and communicate evidence needs. 
• Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, Clinical Study Reports (CSR), epidemiology study results and clinical literature. 
• Develop a strong understanding of the orthopaedic device product portfolio and business needs for clinical evidence to meet regulatory requirements.

Qualifications

• Minimum 5 years of experience within the Medical Device Industry – Orthopaedics – Priority candidates with Trauma experience or Craniomaxillofacial
• New product development and post-market experience
• End to End Project Management experience, able to manage multiple projects simultaneously; Clinical Research experience (study protocols, EU MDR – PMCF planning & execution, data analysis)
• Master’s degree
• Strong communication skills
• Fluency in English

Contract: 12 months with possible extension

Location: Groningen, Netherlands

VGS a Kelly Company is looking for an Injection Molding Engineer.

Role Overview:

Join us to lead cutting-edge projects in injection molding, focusing on optimizing the global raw material supply chain. You'll spearhead initiatives from start to finish, ensuring timely execution, budget management, quality control, and compliance with business policies.

Key Responsibilities:

• Oversee technical projects leveraging Project Management and Six Sigma tools.
• Solve raw material quality issues, working with cross-functional teams.
• Anticipate and resolve supply constraints to maintain continuity and meet demand.
• Drive improvements in injection molding processes and design modifications.
• Manage project budgets, including asset delivery and supplier payments.
• Engage with cross-functional partners to meet project objectives across global sites.

Qualifications:

• Bachelor's degree in engineering or related technical field.
• 5-10 years in engineering within medical devices/pharmaceutical sectors.
• Expertise in injection molding, metrology, GD&T, and related technologies.
• Strong skills in Six Sigma, project management, and communication.
• Experience in regulated medical industries (GMP, compliance).
• Proficiency in English; Dutch is a plus.
• Familiarity with Microsoft Office; Minitab is preferred.
• Willingness to travel (up to 15% globally).

Why Join Us?

Be at the forefront of medical device innovation, collaborate with global teams, and impact the supply chain for essential medical products. Enjoy a dynamic work environment that values excellence and continual improvement.