Regulatory Affairs Professional for Tech Industry

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...

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...

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.

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...

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...

Required Skills and QualificationsBachelor's degree in electrical, control, or electronic engineering.Minimum of 3 years' experience in automation. Previous experience within GMP and Part 11 or alternatively from a related regulatory industry. Experience with SCADA systems, historian, Siemens, WinCC, iFix, Wonderware, etc.Experience in capital project...

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...

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...

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...

Job BriefWe are seeking a highly skilled Senior Automation Engineer to join our team in Uppsala, Sweden. The ideal candidate will have a strong background in automation engineering and experience working with SCADA systems, PLC programming, and manufacturing operations.The successful candidate will be responsible for designing, developing, and commissioning...

We are seeking an Industrial Process Optimization Specialist to enhance our operations, focusing on aseptic processes. You will apply your expertise to optimize production systems, uphold safety and compliance, and collaborate with cross-functional teams.">Key Responsibilities:Develop, implement, and optimize aseptic manufacturing processes to meet quality,...

Meet the Challenge:We are looking for a skilled Procurement Specialist to join our team at Altris in Uppsala. As a key member of our procurement department, you will be responsible for sourcing and evaluating suppliers of process equipment to ensure consistent access to cutting-edge and reliable equipment.Your Key Responsibilities:Sourcing and evaluating...

Galderma OverviewGalderma is a leading global pharmaceutical company that develops, manufactures, and markets innovative treatments for skin health. Our commitment to scientific excellence and regulatory compliance enables us to deliver high-quality products that meet the evolving needs of patients worldwide.Job SummaryWe are seeking a skilled Process...

Galderma's Mission: Delivering Innovation and ExcellenceWe are the emerging pure-play dermatology category leader, dedicated to delivering innovative, science-based solutions that meet the evolving needs of consumers, patients, and healthcare professionals.Our team is driven by a passion for excellence, a commitment to continuous learning, and a focus on...

What We OfferWe offer a competitive remuneration package, including annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits.As part of our innovative and forward-thinking organization, you will have outstanding career and development prospects.

Key Skills and QualificationsThe Automation Engineer should possess a bachelor's degree in electrical, control, or electronic engineering and minimum 3 years' experience in automation.Previous experience within GMP and Part 11 or alternatively from a related regulatory industry is required.The ideal candidate should have experience with SCADA systems,...

Sustainable Future: Energy Procurement ProfessionalWe are committed to creating a sustainable future and are seeking an experienced Energy Procurement Professional to join our team at Altris - Uppsala. If you share our vision and have a passion for driving innovation and sustainability, this role is perfect for you.Key Responsibilities:Source and procure...

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...