Regulator expert

2 weeks ago

Vellinge Municipality, Sweden Sunmedic AB Full time
Vi söker en regulatorisk expert till vårt team på Sunmedic. Som regulatorisk expert kommer du att spela en avgörande roll för att säkerställa att våra medicintekniska produkter uppfyller alla nödvändiga regulatoriska krav. Du kommer att samarbeta nära med andra teammedlemmar, inklusive läkare, utvecklare och testingenjörer, för att säkerställa överensstämmelse med ISO 13485 och CE-certifieringsstandarder.

Huvudansvar:

Genomföra regulatoriska bedömningar och ge vägledning till FoU-avdelningen om efterlevnadskrav.

- Samarbeta med tvärfunktionella team för att säkerställa snabb inlämning av regulatoriska dokument.

- Granskning och uppdatering av teknisk dokumentation, inklusive riskhanteringsfiler, designhistorikfiler och märkning.

- Hålla sig uppdaterad om relevanta regulatoriska krav och kommunicera eventuella förändringar till teamet.

- Delta i revisioner och inspektioner från tillsynsorgan.

- Hjälpa till med att förbereda och lämna in myndighetsansökningar, inklusive CE-märkningsansökningar.

Viktiga krav:

- En gedigen bakgrund inom regulatoriska frågor (MDR), gärna inom medicinteknisk industri.

- Kunskap och förståelse för ISO 13485 och CE-certifieringsstandarder.

- Stark uppmärksamhet på detaljer och förmåga att hantera flera projekt samtidigt.

- Utmärkt skriftlig och muntlig kommunikationsförmåga.

- Förmåga att samarbeta i en tvärfunktionell teammiljö.

- Kunskaper i relevant programvara och verktyg som används i regulatoriska frågor.

- Förtrogenhet med elektronisk hårdvarudesign och agila miljöer.

Vad vi erbjuder:

– Möjligheten att göra ett meningsfullt genomslag inom området avancerad sårvård.

- Ett tillsvidarekontrakt med attraktiva förmåner.

- En bekväm arbetsplats med tillgång till moderna verktyg och teknologier.

- Chansen att samarbeta med ett dedikerat och passionerat team av proffs.

- Stöd för professionell utveckling och tillväxt inom företaget.

Sunmedic är ett företag som drivs av ett gediget uppdrag att betjäna patienter som lider av kroniska sår. Vårt fokus på innovation och efterlevnad av regulatoriska standarder gör att vi kan utveckla tillförlitliga och effektiva medicinska lösningar. Genom att gå med i vårt team kommer du att vara en del av en spännande resa mot att skapa framgångsrika produkter och förbättra patienters liv. Vi ser fram emot att arbeta med dig för att möta nya utmaningar och utveckla vår varumärkeskännedom i branschen.

English:

We are seeking a regulatory expert to join our team at Sunmedic. As a regulatory expert, you will play a crucial role in ensuring that our medical device products meet all necessary regulatory requirements. You will collaborate closely with other team members, including physicians, developers, and test engineers, to ensure compliance with ISO 13485 and CE certification standards.

Key Responsibilities:

- Conducting regulatory assessments and providing guidance to the R&D department on compliance requirements.

- Collaborating with cross-functional teams to ensure timely submission of regulatory documents.

- Reviewing and updating technical documentation, including risk management files, design history files, and labeling.

- Staying updated on relevant regulatory requirements and communicating any changes to the team.

- Participating in audits and inspections from regulatory bodies.

- Assisting in the preparation and submission of regulatory applications, including CE marking applications.

Key Requirements:

- A solid background in regulatory affairs, preferably in the medical device industry.

- Knowledge and understanding of ISO 13485 and CE certification standards.

- Strong attention to detail and ability to manage multiple projects simultaneously.

- Excellent written and verbal communication skills.

- Ability to work collaboratively in a cross-functional team environment.

- Proficiency in relevant software and tools used in regulatory affairs.

- Familiarity with electronic hardware design and agile environments.

What We Offer:

- The opportunity to make a meaningful impact in the field of advanced wound care.

- A permanent contract with attractive benefits.

- A comfortable workplace with access to modern tools and technologies.

- The chance to collaborate with a dedicated and passionate team of professionals.

- Support for professional development and growth within the company.

Sunmedic is a company driven by a solid mission to serve patients suffering from chronic wounds. Our focus on innovation and compliance with regulatory standards allows us to develop reliable and effective medical solutions. By joining our team, you will be part of an exciting journey towards creating successful products and improving the lives of patients. We look forward to working with you to face new challenges and develop our brand awareness in the industry.

Öppen för alla
Vi fokuserar på din kompetens, inte dina övriga förutsättningar. Vi är öppna för att anpassa rollen eller arbetsplatsen efter dina behov.

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