Regulatory Compliance Expert
7 dni temu
LiNA Medical ApS invites applications for a Product R&D Engineer position, offering a unique chance to drive innovation and improve product development. As a key member of our interdisciplinary team, you will contribute to the creation of cutting-edge medical devices and collaborate with cross-functional teams to ensure successful product launches.
Main Responsibilities- Participate in R&D projects, focusing on testing and documentation of new medical devices.
- Play a key role in product management, prioritizing end-user evaluation and implementing new age care activities.
- Lead usability and design validation activities, working closely with cross-functional teams.
- Analyze state-of-the-art products, defining input requirements for projects and conducting pre-clinical tests.
- Support the preparation of technical documentation related to design, development, testing, and regulatory purposes.
- At least 2 years of experience in a similar position, preferably in the medical device industry.
- Familiarity with relevant industry standards (e.g., ISO 13485, ISO 14971, IEC 60601-1) is beneficial.
- Experience with metrological and laboratory equipment, with a willingness to work hands-on with devices.
- Able to work effectively in a team and prioritize workload.
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CMC Regulatory Expert
7 dni temu
Poznań, Greater Poland TN Poland Pełny etatAbout the Job:We are looking for a talented CMC Regulatory Expert to support our Global Regulatory Centres in GSK. The ideal candidate will have extensive experience in regulatory affairs, pharmaceutical industry, and familiarity with CMC regulatory procedures and ICH CTD documentation.Key Requirements:Bachelor's or Master's degree in biotechnology,...
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CMC Regulatory Expert
3 dni temu
Poznań, Greater Poland Randstad Polska Sp. z o.o. Pełny etatAs a Senior Compliance Specialist, you will be responsible for managing multiple CMC variations and source transfers for Finished Products, Intermediates and Active Pharmaceutical Ingredients for pharmaceutical, biopharm and vaccines products (work with the CTD Module 3, Quality part of the dossiers).About the Job:Lead assigned projects: define and agree...
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Regulatory Affairs Specialist
7 dni temu
Poznań, Greater Poland TN Poland Pełny etatJob Description:We are seeking a highly skilled Regulatory Affairs Specialist to join our team in GSK's Global Regulatory Centres. The successful candidate will be responsible for managing multiple CMC new files and CTA assignments for Pharma, Biopharm, and Vaccines products.Your Key Responsibilities:Defining and agreeing regulatory strategies to ensure...
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Senior Regulatory Affairs Professional
6 dni temu
Poznań, Greater Poland Allegro Pełny etatJob OverviewThis is an exciting opportunity for a Senior Regulatory Affairs Professional to join our team at Allegro. The successful candidate will be responsible for ensuring that our operations are in line with regulatory requirements.The ideal candidate will have a solid understanding of compliance and adapting the company to legal acts. Experience...
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Regulatory Systems Business Owner Leader
7 dni temu
Poznań, Greater Poland GlaxoSmithKline Pełny etatGSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together.We are committed to delivering high-quality products to patients worldwide while ensuring the highest standards of regulatory compliance and operational efficiency.About the Role:This role is a key part of our regulatory...
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Regulatory Systems Manager
7 dni temu
Poznań, Greater Poland GlaxoSmithKline Pełny etatAbout UsGSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together. We are committed to positively impacting the health of billions of people and delivering stronger, more sustainable shareholder returns.We are seeking a highly skilled Senior Manager, Regulatory Operations to join our...
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Poznań, Greater Poland GlaxoSmithKline Pełny etatAt GlaxoSmithKline (GSK), we are seeking a talented Senior Manager to join our team as the Business System Owner for Veeva Regulatory Vault. As a key member of our regulatory operations team, you will be responsible for overseeing the strategic management and continuous improvement of this critical business system.This role is instrumental in ensuring that...
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Machinery Compliance Expert
4 dni temu
Poznań, Greater Poland TN Poland Pełny etatSafety Engineer PositionThis role focuses on ensuring that all ROCKWOOL factory production equipment meets regulatory and quality requirements. As a Quality Engineer, you will lead conformity assessments, manage CE-marking processes, and ensure safe integration of new equipment.You will work closely with cross-functional teams, collaborating with engineers,...
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Regulatory Affairs Expert
7 dni temu
Poznań, Greater Poland TN Poland Pełny etatJob DescriptionWe are seeking a Senior Regulatory Specialist to join our Polish Hub. This role is responsible for coordinating and developing the CTA/IND lifecycle strategy, ensuring timely content delivery and compliance with GSK policy and procedures.The successful candidate will be accountable for overall work plans and accountable to individual GRLs/TGs...
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Regulatory Affairs Specialist
3 dni temu
Poznań, Greater Poland Randstad Polska Sp. z o.o. Pełny etatWe are seeking a highly skilled CMC Regulatory Expert to join our team at Randstad Polska Sp. z o.o.Job Description:Manage multiple CMC variations and source transfers for Finished Products, Intermediates and Active Pharmaceutical Ingredients for pharmaceutical, biopharm and vaccines products (work with the CTD Module 3, Quality part of the dossiers)Lead...
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Global Regulatory Compliance Specialist
3 dni temu
Poznań, Greater Poland GlaxoSmithKline Pełny etatThe Senior Manager, RIM & Data Office at GlaxoSmithKline is responsible for ensuring the timely execution of RIM based requests and delivery of RIM initiatives and projects. This includes overseeing operational teams and leading matrix teams across the broader Regulatory Information Management & Data Office and Global Regulatory Operations group,...
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Financial Compliance Specialist
3 dni temu
Poznań, Greater Poland TN Poland Pełny etatJoin us at TN Poland and become part of a talented team dedicated to shaping the future of financial services! As a Global Banking Regulations Expert, you will contribute to developing and implementing robust compliance programs that ensure our business practices meet the highest standards of integrity.Your key responsibilities will include:Staying...
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Senior Cybersecurity Professional
7 dni temu
Poznań, Greater Poland TN Poland Pełny etatJob OverviewWe are seeking a highly skilled Senior Cybersecurity Specialist to join our team in a key role that focuses on IT risk management and regulatory compliance.This role requires a deep understanding of cybersecurity frameworks, standards, and best practices, as well as excellent communication and interpersonal skills to work effectively with diverse...
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Regulatory Portfolio Manager
6 dni temu
Poznań, Greater Poland TN Poland Pełny etatAbout the RoleWe are seeking a highly skilled Regulatory Portfolio Manager to join our team at TN Poland. As a key member of our regulatory affairs department, you will be responsible for ensuring the development and execution of regulatory strategies for our Classic & Established Product (CEP) portfolio.Your primary objective will be to maintain compliance...
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Director of Regulatory Operations
7 dni temu
Poznań, Greater Poland GlaxoSmithKline Pełny etatAbout the RoleWe are seeking a highly skilled Senior Manager, Regulatory Operations to lead our Veeva Regulatory Vault team. As the Business System Owner (BSO), you will be responsible for overseeing the strategic management and continuous improvement of this business-critical system.As BSO, you will ensure that Reg Vault is effectively supporting global...
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Regulatory Project Manager
4 tygodni temu
Poznań, Greater Poland TN Poland Pełny etatJob DescriptionWe are seeking an ambitious Regulatory Project Manager to lead the development of regulatory strategies and their execution for assigned assets, ensuring compliance with internal GSK processes and external regulatory requirements.The successful candidate will create a place where people can grow, be their best, be safe, and feel welcome,...
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Strategic Regulatory Lead
6 dni temu
Poznań, Greater Poland TN Poland Pełny etatKey ResponsibilitiesAct as Global Regulatory Lead: Drive matrix team engagement for CEP portfolio assets and take ownership of lifecycle maintenance, including discontinuation of Marketing Authorizations (MAs).Lead Communication with Regulatory Agencies: Be the main point of contact with the European Medicines Agency and other European Local Health...
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Pharmaceutical Regulatory Professional
3 dni temu
Poznań, Greater Poland Randstad Polska Sp. z o.o. Pełny etatWe are looking for a Regulatory Affairs Specialist to join our team at Randstad Polska Sp. z o.o.About the Role:Manage multiple CMC variations and source transfers for Finished Products, Intermediates and Active Pharmaceutical Ingredients for pharmaceutical, biopharm and vaccines products (work with the CTD Module 3, Quality part of the dossiers)Lead...
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Regulatory Systems Business Owner
6 dni temu
Poznań, Greater Poland GlaxoSmithKline Pełny etatAbout the RoleWe are seeking a highly skilled Regulatory Systems Business Owner to join our team at GlaxoSmithKline (GSK). As a key member of our organization, you will be responsible for overseeing the strategic management and continuous improvement of our User Access Management (UAM) application and X-Vault platform.This role requires a deep understanding...
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Poznań, Greater Poland TN Poland Pełny etatCompany OverviewGSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with...