
Global Regulatory Manager
6 days ago
Job Title: Regulatory Affairs Manager
Location: Global
Job Description
We are seeking a highly skilled Regulatory Affairs Manager to join our team. This individual will be responsible for ensuring that our products conform to local regulations and laws.
Responsibilities
- Key Responsibilities:
- Analyse regulatory requirements and connect them to product documentation to ensure compliance.
- Work closely with cross-functional teams to identify regulatory pathways and translate them into requirements to enable product registration in prioritized markets.
- Plan and prepare technical documentation and submission dossiers for FDA and expedite approval of pending applications.
- Monitor and interpret regulations, standards, and guidelines and communicate their impact.
- Conduct regulatory actions such as pre-submission, dossier preparation, license renewals, change notifications, etc., to enable successful product launch and product license maintenance.
Qualifications
- A university degree and regulatory affairs experience within the medical device or in-vitro diagnostics industries.
- Ability to articulate regulatory requirements translated into business impact and opportunities.
- Experience in working within an IVD/Medical Device environment (EU IVDR, ISO 13495).
- Experience in preparation of regulatory documentation including pre-submissions, 510(k)s, CE-IVDR technical documentation, etc.
- Knowledge of specific considerations related to software and cybersecurity in a regulatory context.
- Excellent written and verbal communication skills in English.
-
Uppsala, Uppsala, Sweden Cytiva Sweden AB Full timeBring more to life.Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?At Cytiva, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact.You'll thrive in a culture of belonging where you and your unique...
-
Senior EHS Manager Role
7 days ago
Uppsala, Uppsala, Sweden Danaher - Global Full timeAccelerate your impact.Cytiva seeks a seasoned EHS professional to lead our team in Uppsala, Sweden. As EHS Director, you will be responsible for developing and implementing effective environmental, health, and safety strategies that align with Danaher's global best practices.This role requires strong leadership skills, excellent communication, and the...
-
Regulatory Compliance Manager
6 days ago
Uppsala, Uppsala, Sweden Rarity Bioscience Full timeQuality ExpertiseWe are seeking an experienced Quality Specialist to join our team at Rarity Bioscience. As a key member, you will be responsible for ensuring the highest standards of quality and regulatory compliance across our operations.Key ResponsibilitiesQuality Management System: Implement and maintain our ISO 13485 quality management system to ensure...
-
Regulatory Affairs Specialist
6 days ago
Uppsala, Uppsala, Sweden Thermo Fisher Scientific Full timeCompany OverviewThermo Fisher Scientific is a global leader in the development, manufacturing, and selling of blood test systems for clinical diagnosis and monitoring of allergy, asthma, and autoimmune diseases.We are proud to be at the forefront of this field with 1,900 employees worldwide, 1,000 of which are in Sweden.Job DescriptionThis role is part of a...
-
Director of Workplace Safety
7 days ago
Uppsala, Uppsala, Sweden Danaher - Global Full timeTransform workplace safety.Cytiva is seeking an experienced EHS Director to lead our team in Uppsala, Sweden. In this role, you will be responsible for transforming workplace safety through the development and implementation of effective EHS programs, policies, and procedures.This position requires strong leadership skills, excellent communication, and the...
-
Global Trade Operations Coordinator
2 days ago
Uppsala, Uppsala, Sweden Danaher - Global Full timeJob SummaryThe Global Trade Operations Coordinator will play a critical role in ensuring the smooth execution of our import and export processes while maintaining compliance with all relevant regulations.Main Responsibilities:Oversee the coordination of import/export processes, including clearance procedures, documentation, and customs...
-
Global HR Business Development Partner
7 days ago
Uppsala, Uppsala, Sweden Danaher - Global Full timeDrive ImpactCyctiva is at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.We are looking for a Senior HR Business Partner to join Cyctiva's global BioProcess...
-
Environmental Health and Safety Director
7 days ago
Uppsala, Uppsala, Sweden Danaher - Global Full timePromote a culture of safety.We are seeking a dedicated EHS Director to join our team in Uppsala. In this role, you will be responsible for creating and maintaining a positive safety culture by leading a team of 18 EHS professionals and collaborating with site leaders to enhance safety awareness and accountability.This position requires a deep understanding...
-
Customs and Compliance Manager
2 days ago
Uppsala, Uppsala, Sweden Danaher - Global Full timeCustoms and Compliance Manager Job DescriptionWe are seeking an experienced Customs and Compliance Manager to join our global trade operations team. This individual will be responsible for ensuring our import and export activities comply with all relevant laws and regulations.Key Accountabilities:Manage customs and compliance risks associated with our import...
-
Human Resources Manager Senior
7 days ago
Uppsala, Uppsala, Sweden Danaher - Global Full timeTransform Human HealthWe're a leader in providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.The Senior HR Business Partner will be responsible for providing leadership and...
-
Regulatory Affairs Coordinator
7 days ago
Uppsala, Uppsala, Sweden Danaher - Global Full timeBenefitsWe offer a dynamic and supportive work environment, opportunities for professional growth and development, and a competitive compensation package. If you are a highly engaged and self-motivated individual with excellent networking, interpersonal, and communication skills, we encourage you to apply for this exciting opportunity.
-
Senior Quality Systems Specialist
7 days ago
Uppsala, Uppsala, Sweden Danaher - Global Full timeJob DescriptionAs a Senior QA Specialist, you will play a critical role in ensuring the effectiveness of our Quality Management System (QMS) and its documentation. Your responsibilities will include leading the QMS Documentation Review Board, acting as Site Subject Matter Expert for our document management system (eDMS), and monitoring changes in global and...
-
Global HR Manager
3 days ago
Uppsala, Uppsala, Sweden Thermo Fisher Scientific Full timePosition Overview:The HR Manager will play a critical role in driving business success by developing and implementing effective HR strategies, policies, and procedures. This position requires strong analytical skills, attention to detail, and excellent communication skills. The ideal candidate will have experience in human resources, handling diverse and...
-
Quality Assurance Manager
7 days ago
Uppsala, Uppsala, Sweden Danaher - Global Full timeCompany OverviewDanaher - Global is a leading provider of innovative solutions for the life sciences, diagnostics, and biotechnology industries. With a commitment to excellence and a passion for making a real difference, we are shaping the future of human health.
-
Pharmaceutical Automation Manager
6 days ago
Uppsala, Uppsala, Sweden Galderma Full timeGALDERMA IS THE LEADING PURE-PLAY DERMATOLOGY COMPANY PRESENT IN APPROXIMATELY 90 COUNTRIES. WE DELIVER A SCIENCE-BASED PORTFOLIO OF PREMIUM FLAGSHIP BRANDS AND SERVICES THAT SPAN THE FULL SPECTRUM OF THE FAST-GROWING DERMATOLOGY MARKET THROUGH INJECTABLE AESTHETICS, DERMATOLOGICAL SKINCARE, AND THERAPEUTIC DERMATOLOGY.We are seeking a highly skilled Senior...
-
Senior Mechanical Engineering Team Manager
3 days ago
Uppsala, Uppsala, Sweden Danaher - Global Full timePioneer Innovative SolutionsDanaher - Global is a global leader in life sciences and diagnostics, driving innovation and progress in the industry. Our mission is to make a tangible impact in the lives of people around the world.We're looking for a seasoned Senior Mechanical Engineer to serve as a Technical Lead in our Hardware Engineering section within...
-
Trade Compliance Specialist
2 days ago
Uppsala, Uppsala, Sweden Danaher - Global Full timeAbout the RoleWe are seeking a highly skilled Trade Compliance Specialist to join our team. As a key member of our global trade operations department, you will be responsible for mitigating customs and compliance risks associated with our import and export processes.Key Responsibilities:Ensure trade compliance rules and regulations are met and manage trade...
-
Senior Manager of Finance and Strategy
2 days ago
Uppsala, Uppsala, Sweden TN Sweden Full timeThermo Fisher Scientific's Finance teams play a vital role in enabling business growth and supporting functional teams to make informed decisions. As a world leader serving science, we are ranked #95 on the Fortune 500 list and have revenues exceeding $40 billion.The Immunodiagnostics Division is a significant contributor to our organization, with over 2000...
-
Marketing Manager
7 days ago
Uppsala, Uppsala, Sweden Wehype Global AB Full timeWehype Global AB: Driving Innovation in Gaming and Creator CollaborationsWe are looking for a talented Marketing Manager to help shape the future of gaming collaborations. As a key member of our team, you will be responsible for developing and executing marketing strategies that drive awareness, engagement, and trust within our ecosystem of game studios,...
-
HR Director
7 days ago
Uppsala, Uppsala, Sweden Danaher - Global Full timeDrive Organizational EffectivenessWe're at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.The Senior HR Business Partner will be responsible for serving as a...