Global Regulatory Affairs Lead

Job OverviewWe are a leading global company in the field of in-vitro allergy testing and autoimmunity diagnostics, with over 1,900 employees worldwide.This role is critical in business-critical projects, developing and implementing regulatory strategies, and collaborating closely with regional Regulatory Affairs colleagues and internal teams.

RequirementsUniversity degree and experience in regulatory affairs within the medical device or in-vitro diagnostics industries.Ability to articulate regulatory requirements translated into business impact and opportunities, with a good understanding of regulations globally.Additionally, you should have experience in working within an IVD/Medical Device...

Career OpportunitiesJob Description: We are seeking an exceptional individual to join our team as a Commissioning and Qualification Expert. This role will involve coordinating and executing commissioning activities for new facilities, ensuring seamless transitions and compliance with regulatory requirements.Required Skills: Strong understanding of...

Key ResponsibilitiesCollaborate with cross-functional teams to identify regulatory pathways and translate them into product registration requirements in prioritized markets.Develop and prepare technical documentation and submission dossiers for FDA approval and expedite pending applications.As a key member of our Regulatory Affairs team, you will be...

Life-Changing Opportunities in Life SciencesCytiva, a leading global player in life sciences, is driven by a passion to improve human health and save lives through innovative solutions.You'll thrive in a dynamic environment where your skills and expertise will make a significant impact on our mission.Our work enables breakthroughs in biotechnology, vaccine...

Responsibilities and RequirementsEnsure regulatory compliance through effective quality control measures.Liaise with suppliers to evaluate and approve their quality systems.Train team members on quality procedures and best practices.Foster a culture of continuous improvement within the organization.

About the RoleThe Global Product Manager Lab Resins will lead cross-functional teams on the journey to successfully launch new products by developing selling propositions, pricing tactics, customer support, business plans, and sales support.You will be responsible for developing a multi-year product roadmap, plan for future positioning, growth, and evolution...

Job Summary:Nordberg Medical is seeking a seasoned Regulatory Compliance Expert to lead our QA efforts. As a key member of our team, you will be responsible for ensuring that all QA processes are aligned with regulatory requirements and company policies.The ideal candidate will possess extensive experience in quality assurance, regulatory compliance, and...

Company OverviewGalderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, 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...

About Us:We are Galderma Pharma S.A., the emerging pure-play dermatology category leader, present in approximately 90 countries. Our innovative, science-based portfolio of premium flagship brands and services caters to the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology.Our team is...

Driving Business Growth through Effective Service DeliveryCytiva is seeking an experienced Service Project Manager to lead our PLP development projects and ensure seamless coordination among teams and stakeholders. As part of our Global Service Readiness Engineering Team, you will work closely with primary project leaders, service engineering leads, and...

Job SummaryWe're seeking an experienced Hardware Engineering Team Lead to join our Downstream Hardware R&D section within Danaher - Global's hardware engineering organization. This role will lead and coordinate tasks for a team of engineers specializing in mechanics, electronics, optics, embedded systems, and testing.

Om oss: Agap2 Sweden är en ledande aktör inom Life Science-industrin. Vi erbjuder en inkluderande arbetsmiljö där ditt engagemang och din kompetens värdesätts. Vår arbetsplats prioriterar sammanhållning, med regelbundna uppföljningar med din konsultchef samt aktiviteter som event, middagar och AWs. I rollen som Senior Manager Regulatory Affairs...

Om rollen: Den här tjänsten är perfekt för dig som vill vara en del av ett dynamiskt team och bidra till att säkerställa att våra produkter uppfyller regulatoriska krav. Som Senior Manager Regulatory Affairs kommer du att arbeta nära kollegor och andra intressenter för att säkerställa efterlevnad av lagar och regelverk inom produkt- och...

Optinova Nordic Ab/Seola Ab is a world-leading partner in advanced medical and industrial tubing extrusion. Our Business Systems and Transformations (BST) unit focuses on business systems management and strategic transformation programs. We are currently seeking an experienced Global ERP System Lead to join our team.The Global ERP System Lead will be...

Job OverviewWe are seeking talented individuals to join our team as Senior Manufacturing Scientists. As a key member of our MS&T department, you will play a crucial role in implementing new products into our manufacturing facilities, ensuring seamless integration with existing processes.As a Subject Matter Expert, you will collaborate closely with...

Unlock New Challenges at Danaher - GlobalAbout the JobThe Downstream Hardware R&D organization continues to grow, and we are now looking for a Senior Manager to lead our Embedded Software team.Key ResponsibilitiesDevelop and implement strategies to drive business growth and success.Build and maintain strong relationships with cross-functional teams and...

Unlocking Potential through Strategic CollaborationThe Service Project Manager role at Cytiva presents an exciting opportunity to drive impactful results through collaborative efforts. As part of our Global Service Readiness Engineering Team, you will work closely with primary project leaders, service engineering leads, and extended service teams to...

About the RoleAt Galderma, we are seeking highly skilled professionals to join our team as Senior Manufacturing Scientists. In this role, you will serve as a subject matter expert responsible for new product implementation into a manufacturing facility, ensuring seamless support of upstream processes and assembly and packaging processes during commercial...

Galderma, the emerging leader in dermatology, operates in over 90 countries. We deliver a portfolio of premium brands and services across the full spectrum of the fast-growing dermatology market through Injectables, Skincare, and Therapeutic Dermatology.Job Title: Senior Manufacturing Scientist, BiologicsAbout the Role:This position is responsible for...