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Regulatory Affairs Specialist

Regulatory Affairs Specialist Are you passionate about bringing safe and effective medical devices to market with speed and agility? My client, a global leader in the design, manufacture, and distribution of cutting-edge mobility devices is seeking a promising Regulatory Affairs Specialist to join their European team. Ready to put your skills to work? Your Tasks: Implement quality system components focused on regulatory compliance with MDR 2017/745, ISO 13485 and ISO 14971 Manage projects and activities for the improvement of products and processes from a regulatory standpoint Monitor and ensure the compliance of regulatory requirements (Europe, Switzerland & UK) Manage CAPA system, track recalls and FSCAs Participate in risk assessment activities such as UFMEA Collaborate with the Quality Director Europe to ensure documentation is compliant Assist in liability claim investigation and document collection Your profile: Fluent in English and at least intermediate knowledge of German 2+ years professional experience in regulatory affairs or quality management relating to medical devices Thorough knowledge of regulatory requirements (e.g. MDR, ISO 13485 & ISO 14971) Computer proficiency with MS Office Strong communication skills, good organizational skills, analytical thinking and a high level of reliability Please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. +49 30 16639819 #LI-VU1
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Finance Manager

ParisFrance70,000 - 90,000EUR + bonus + company car
Finance Manager Our client, a leading manufacturer near Paris, is currently looking for a Finance Manager to strengthen their team and lead financial reporting activities. The role includes overseeing a skilled finance team and implementing strategies to optimize cash flow, ensuring financial efficiency and sustainability. Key tasks: Lead financial reporting ensuring adherence to group-wide accounting policies. Manage and mentor a finance team and optimize cash position. Support statutory tax and financial reports. Oversee Accounts Payable, Accounts Receivable, Payroll, and Fixed Asset Ledgers with high accuracy. Manage site cost accounting system, including standard cost roll, cost analysis, and material usage variances. Collaborate with Corporate Finance to evaluate and implement accounting policies. Improve finance processes for efficiency gains and value addition. Lead annual budgeting, 3-year planning, and monthly P&L forecast processes. Coordinate external audits, statutory reporting, and Corporation Tax returns. What is required: MA, MSc, or MBA in Business Management. 7+ years of relevant experience in finance/accounting within global manufacturing. Proven ability to meet tight reporting deadlines. Positive attitude, team player, and a proactive learner. Supervisory experience and familiarity with multi-currency transactions in a global setting. Fluent English and French both spoken and written. Willingness to travel to various European sites. Effectively collaborates with cross-functional teams. If you're interested in this position, please contact Dominika Wyrwinska for more details. #LI-DW1
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Payroll Specialist

Our client is a global respiratory diagnostics leader and is currently looking for a Senior Specialist HR Payroll. Job Summary: • Operational payroll standards and processes have to be kept on high professional level to ensure positive stakeholder experience • Responsible for accuracy of payroll data, and researches data integrity issues. • Serve as the primary point of contact for employee payroll questions. • Responsible for ensuring a smooth and professional payroll process in order to satisfy the customers needs in line with Vyaire processes • First contact point for managers and employees for payroll related questions • Support returning HR processes • Member of the Global Payroll Team as well as working closely with the members on the objectives Required Qualifications: Education: Completed apprenticeship Further training in HR (payroll specialist) preferred Fluent German and English speaker Minimum of 5 years of German payroll experience - Experience with external payroll providers Knowledge: Profound current knowledge of german payroll processes as well as tax and social security law and retirement funds Knowledge of a common payroll programme (preferably Sage) Good problem-solving abilities, strong understanding of numbers and analytical skills High level of customer orientation, sense of responsibility and initiative Hands-on experience with Office 365 package ESSENTIAL DUTIES AND RESPONSIBILITIES: Independent and autonomous preparation of payroll accounting including all preparatory and follow-up activities, Independent execution of the monthly payroll including transmission of the data to the social security institutions, tax office and financial accounting Clarification and evaluation of payroll tax and social security issues Comprehensive recording and maintenance of personnel master data Taking care of absences, especially maternity leave, parental leave, illness, including communication with health insurance companies . Maintenance and monitoring of absences including certification to health insurance companies Social security assessment of special employments (e.g. interns, students, mini[1]jobbers, partial retirement) Preparation and follow-up, monitoring and administrative implementation of special employment relationships (in particular maternity/parental leave and partial retirement) including insurance coverage Executing of capital-forming benefits, direct insurance, deferred compensation and retirement provisions Processing of enquiries from social security institutions, the tax authorities and other authorities and institutions Support with necessary monthly, quarterly and annual financial reporting including preparation and reconciliation of data for and with accounting (salary postings, personnel provisions, etc.) Coordination, supervision, pre and post processing of internal and external audits by auditors, tax authorities and social security institutions Close cooperation with the local personnel departments of our internal client companies as well as interface with local financial accounting departments Continuous further development of payroll-relevant processes Please apply with your CV or contact Sanela Hasanovic for further details on this opportunity: Sanela Hasanovic +4915123483158  Mobile #LI-SH2 #LI-Hybrid
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Freelance IVDR Expert

Freelance IVDR Expert Our client is a globally leading manufacturer of IVDs, looking for 12+ months of support for IVDR readiness and audits.  Topics to cover: Definition, support, and monitoring of transition and improvement Plans Carrying out internal audits, making sure to cover all relevant requirements IVDR Lead Management Review with emphasis on IVDR compliance Actively involved in formulating, establishing, and enhancing protocols and work instructions to ensure compliance with IVDR Rate: Open to discussion, travel costs paid Flexibility: Minimum 60% on-site in Frankfurt, 40% home office possible Duration: 12 - 18 months Hours: 60 - 100% Please reach out to for more information or call +49 30 16 63 93 35 #LI-RS5
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Freelance QMS/Document Control Expert

Freelance QMS/Document Control Expert Our client is a globally leading manufacturer of IVDs, looking for 10+ months of support for IVDR QMS, document control, and tool implementation.  Topics to cover: Document & Record Control / Procedures / Tool Implementation  Review of current system including: work instructions, templates, policies, processes, procedures, and records  Definition, support, and monitoring of transition and Improvement Plans Streamlining, Consolidation, and Structure Building The organisation as a whole should implement "GDocP" (good documentation practices) and Document & Record Control Training. Process owners, department leaders, and staff should be supported. An electronic Document & Record Management System (eDMS) should be defined and put in place. Participates actively in creating, refining, and enhancing work instructions and procedures (only for document and record control). Rate: Open to discussion, travel costs paid Flexibility: Minimum 60% on-site in Frankfurt, 40% home office possible Duration: 12 - 18 months Hours: 60 - 100% Please reach out to for more information or call +49 30 16 63 93 35 #LI-RS5
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Quality Manager

TuttlingenGermany70,000EUR - 75,000
Quality Manager Overview With roots dating back to 1930s, our client is dedicated to specializing in high-quality endoscopy products. With them, you can enjoy the personal benefits of creative freedom, collaboration within a collegial team, and the security of our international group structure as well as experience innovation, access tailored training for professional and personal growth, and work in modern, ergonomic spaces with additional perks. Would you like to elevate your career by expanding expertise in quality management, supplier quality and technical documentation, engaging with a diverse product portfolio? This is your chance! Tasks Maintain and further develop the quality management system in accordance to ISO 13485 Support and participate in internal and external audits (e.g. certifications) Ensure compliance with applicable industry regulations and requirements as well as legal norms and guidelines Maintain work instructions and procedural Take an active role in the creation and maintenance of technical documentation Represent the company externally during audits to prospective suppliers, partners or regulatory authorities Your profile Apprenticeship or vocational training as an industrial clerk, complemented by additional training and interest in technology and medical products or equivalent 4+ years of experience in MedTech industry and in areas such as Quality Management, Audits and Technical Documentation Solid foundational knowledge of relevant regulatory and normative requirements (MDD, MDR, ISO 13485 etc.) Team player who can also work independently Fluency in English and German Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. +49 30 1663 7750 #LI-MC2  
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Clinical Integration Engineer Global Customer Support

RemoteGermanyopen to discuss
Our client is the only global company focused exclusively on breathing through every stage of life. Its portfolio of integrated solutions ensure all breathing needs are met to enable, enhance, and extend lives. The team is inspired and empowered to elevate the quality of each inhale and each exhale. Experience: Technical and / or commercial sales Experience in complex structures within the hospital environment Safe dealings with customers Ability to move customers to action Strong sales performance Strong sales mindset Willingness to travel incl. overnight stays Knowledge: Sales negotiations and deals with buyers in a hospital, doctors, as well as other decision-makers. Knowledge of Medical Devices Low Germany Safe handling of MS Office applications Word,Excel, PowerPoint and Outlook. Knowledge of spoken and written English. Goals of the job: Achievement of the specified sales targets in the assigned sales area. Strong focus on numbers an goals Team player  Improve patient outcomes and provide greater value for our customers Maintaining and expanding market position. Take care of existing customers Acquisition of new customers Work to be carried out (main tasks): Consulting and sale of  lung function (PFT) and ergospirometry (CPET) products. Sales negotiations and deals with purchasers, general practitioners and other decision-makers. Planning and execution of trial orders Participation in trade fairs Independent planning of trips, if necessary also with overnight stays Reporting of business-relevant numbers - regular forecast – Maintaining “Salesforce” Maintaining and Evaluating a Project List Market and competition monitoring Please apply with your CV or contact Sanela Hasanovic for further details on this opportunity: Sanela Hasanovic +4915123483158 Mobile #LI-SH2 #LI-Hybrid
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Product Quality Manager RDx

Our client is a unified breathing company that focuses on improving the lives of those treated with our devices. They are a recognized leader in the Respiratory Diagnostics, Ventilation, and Anesthesia Delivery & Patient Monitoring market segments. They are also the largest pure-play company of its kind. We empower our people to challenge the status quo while pioneering innovation; in order to continually provide solutions that restore and maintain patients’ vitality and independence, while also increasing our value to our clients. · Job Summary: The Product Quality Manager is the a critical role for all Quality issues related to each product or product line in  Respiratory Diagnostics Franchise. The Product Quality Manager will develop and maintain deep cross-functional support throughout the entire product life cycle, from inception through design and development, design transfer, production, ongoing support for devices on the market, and product end-of-life. This role leads the Product Quality Team and associated sub-teams: Design Assurance and Risk Management. The Product Quality Manager will lead a team of Product Quality Navigators who will support specific products or product families. · Required Qualifications: Education: A Bachelor’s Degree in a relevant field; degrees in Product Design, Electrical or Mechanical Engineering, Life Science, or Quality/Regulatory disciplines preferred A Master’s Degree such as an MBA or another related discipline would be an advantage Experience: Required 5-6 years of experience with Medical Devices or a Healthcare relevant industry 4-5 years of experience with Design Assurance Working knowledge of regulations and standards affecting Medical Device manufacturing (e.g. MDD/MDR, FDA, ISO, Quality System Requirements). Demonstrated experience with the development, implementation, and management of quality system procedures/practices. Moderate knowledge and understanding of Risk (14971) for medical devices Knowledge: Deep knowledge of product development. Strong working knowledge of current international and company regulatory compliance requirements and operating procedures, including (but not limited to) FDA, ISO 13485, ISO 14971, ISO 62366, MDSAP, European Medical Device Directive and Medical Device Regulation, MDCG, and applicable industry standards. Knowledge of Medical Industry Design Controls, V&V, design & development best practices as well as Risk Management for Medical Devices. Practical knowledge of Active Medical Devices PC, MS Office applications, Software Systems Fluent or Native German required with functional business-level written and spoken English · Objective: Lead and support a Quality Product Function providing broad and deep support for all products in the RDx family. Manage Product Quality and sub-teams inside the function. Manage Product Quality, Design Assurance, Risk Management activities and related regulatory obligations during the product life cycle for the Höchberg RDx product range to support the placement of high-quality medical devices on the market and positively impact patient outcomes. Note: This role requires a clear End-User & Patient-Centric perspective · Essential Duties (Primary Tasks): - Become a Quality subject matter expert for all quality assurance activities relating to each product and product line. - Participate in continuous improvement activities. - Perform trending of quality data, ensuring proper application of CAPA and feedback loops are effective. - Independently produce, organize, and maintain documentation or systems critical to the function of product quality. - Provide Quality guidance during the initial ideation, prototyping, and design phase for new products and support each stage of product development. - Process ownership for product quality metrics. - Understand and able to apply ISO13485 and particularly ISO 62366 as well as any other regulatory requirements within the product life cycle. - General research, documentation, and file/ database maintenance. - Ensure compliance of our medical devices with the GSPR of the MDR. Please apply with your CV or contact Sanela Hasanovic for further details on this opportunity: Sanela Hasanovic +4915123483158 Mobile #LI-SH2
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