Regulatory Affairs Specialist

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...

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...

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 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...

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...

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.

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...

Rare Opportunity: Raw Materials SpecialistWe are seeking a seasoned Raw Materials Specialist to join our team at Altris - Uppsala. This is a unique chance to work with a leading company in the energy storage industry and contribute to its continued success.About the Role:Main Responsibilities:Source and procure high-quality raw materials from reliable...

Rollbeskrivning: Vi söker en erfaren Senior Manager Regulatory Affairs till vår kund i Uppsala. Rollen innefattar arbete med regulatoriska processer kopplade till biologiska läkemedel, kemiska läkemedel och medicintekniska produkter.Uppgifterna består av att implementera och utveckla regulatoriska strategier, processer och policys i enlighet med...

Job OverviewTN Sweden is committed to addressing the IT skills gap by focusing on headhunting and recruiting for challenging roles. Our strategy is centered around developing models to attract and engage top talent, leveraging an agile approach, strong networks, and close cooperation with our customers.As a Compliance Manager at IAR, you will be part of a...

Overview of the Role:At Nordberg Medical, we are seeking a skilled Quality Assurance Specialist to join our team. This individual will play a vital role in ensuring the quality and safety of our products by managing all aspects of QA within the manufacturing process.The ideal candidate will possess excellent communication and problem-solving skills, as well...

About the RoleThe roles act as subject matter experts responsible for new product implementation into a manufacturing facility, and for support of upstream processes and assembly and packaging processes during commercial manufacturing.Your Key ResponsibilitiesDevelop NPI strategies and support all aspects of process validation, including writing 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...

We are seeking a talented Biologics Process Specialist to join our team at Galderma. As a key member of our manufacturing science and technology department, you will be responsible for supporting new product implementation strategies and process validation. Your expertise in biopharmaceutical manufacturing processes will be essential in ensuring the quality...

About the Position:We are seeking a skilled Compliance and Validation Specialist to join our quality assurance team at TN Sweden. In this role, you will be responsible for ensuring that our validation processes comply with regulatory requirements and industry standards.Key Responsibilities:Develop and Implement Compliance Strategies: Collaborate with...