We are looking forward to you joining as a

(Senior) Consultant Regulatory Affairs Specialist – Submissions (m/f)

Compliance Consulting

Location: Basel or Zürich

ARCONDIS is the largest management consultancy exclusively specializing in the Life Sciences sector in the DACH region. Since 2001, we have been managing challenges and projects for our clients in the areas of Compliance, Information Management, IT Management and Business Process Transformation.

Your tasks and responsibilities:

• Customer assignments in the area of regulatory consulting


• Comprehensive content consulting and coaching in regulatory submission issues


• Supporting customers in defining new RA processes, systems, roles and responsibilities


• Business development and acquire new challenges independently


• Stakeholder management (at senior management level)


• Project Management

Your profile:

• Over 3 years ( over 5 years senior) experience in Regulatory affairs with medical devices or in pharma


• Experience in NDA or 510(k) (in MedTech) submissions for regulatory approval in the US markets and / or Experience in submissions for regulatory approval and maintenance of the approval in other markets (JP, CN, CAN, EU, …)


• Experience in working together with the FDA, Swiss Medic, notified bodies and/or other regulators and health authorities to ensure regulatory approval (including experience with the different portals for uploading of documents)


• Experience in the compilation of the technical documentation


• Experience with a minimum class IIb products (MedTech)


• Must have knowledge in country-specific pharmaceutical legislations and / or MDR respectively, IVDR strongly preferred


• Knowledge of US and / or other guidelines applicable for regulatory approval


• Communicative and open personality


• Fluent in English and German (word and writing)


• Project Management highly desirable


• Excellent editing and proofreading skills with attention to detail

Here you will find informations on additional benefits and career opportunities.

Apply now!