Senior Regulatory Consultant providing strategic regulatory support to pharmaceutical companies. Collaborating on regulatory activities across the EU and US, ensuring compliance and successful submissions.
About the role
- Regulatory Affairs Consultant in Medtech/IVD, supporting clients through product lifecycle. Involved in regulatory strategies, submissions, and compliance with EU and FDA regulations.
Responsibilities
- Utforma regulatoriska strategier och guida kunder i komplexa regelverk (EU MDR/IVDR, FDA, MDSAP m.fl.).
- Arbeta med regulatoriska ansökningar, submissions och interaktion med myndigheter och notified bodies.
- Säkerställa korrekt och komplett teknisk dokumentation.
- Bidra till klinisk och prestandautvärdering samt implementering av tillämpliga standarder.
- Vara en aktiv del i utvecklingsprojekt där regulatoriska krav måste integreras tidigt.
- Dela kunskap och bygga kompetens tillsammans med vårt erfarna RA-team.
Requirements
- Minst 3 års erfarenhet av Regulatory Affairs inom medicinteknik eller IVD.
- Högskole- eller universitetsexamen inom Life Science (t.ex. civilingenjör, BMA eller PhD).
- Dokumenterad erfarenhet inom ett eller flera av följande områden:
- EU MDR/IVDR och tillhörande vägledningar.
- FDA-ansökningar (510(k), De Novo, PMA) och andra regulatoriska pathways.
- MDSAP och internationella regulatoriska krav.
- Standarder för riskhantering, säkerhet och prestanda (ISO 14971, IEC 60601, IEC 62366, ISO 15189).
- Teknisk dokumentation samt klinisk/prestandautvärdering.
- Mycket goda språkkunskaper i svenska och engelska.
Benefits
- Välkommen att skicka in din ansökan så snart som möjligt.
- Urval och intervjuer sker löpande.
- Att vara en del av Team PV.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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