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IVDR Regulatory Affairs
& Quality Manager

Picto experience

3-years experience

Picto location

On-site / remote

Picto salary

Negociable

At BIOSHARE SOLUTIONS, we aim to improve & accelerate patient diagnosis by offering new innovative solutions.

BIOSHARE SOLUTIONS is a distribution company created with the aim of reducing the discovery cycle of innovative technologies to bring them to the healthcare market, enabling them at the forefront where most needed.

BIOSHARE SOLUTIONS offers an exciting position for an experienced IVDR Regulatory Affairs & Quality Manager, to support global trading of Life Sciences and IVD products, alongside Authorized Representation services in Europe.

This permanent role is based in Montpellier, France (Headquarters) and/or remotely in France or Spain and will offer you the opportunity to enable Business growth worldwide.

Directly reporting to the Senior Director Quality, Regulatory & Compliance, you will be at the forefront of the strategic development of BIOSHARE SOLUTIONS business.

Your responsibilities

  • Collaborate with the Company Leadership by providing regulatory guidance for IVD and non-IVD businesses within Europe and abroad, covering importation, worldwide distribution, and representation of foreign manufacturers to the European authorities and markets.

  • Structure the Company QMS and processes set-up to ensure Customers’ needs, suppliers’ conditions, products’ storage and transports conditions and traceability requirements are met.

  • Collaborate with suppliers’ regulatory and quality teams to enable Marketing Authorization applications in targeted countries.

  • Support sub-distributors and local agents with regulatory filings.

  • Compile, review and maintain regulatory submissions / Marketing Authorizations (importer role) and review regulatory compliance of products for further distribution in Europe and abroad.

  • Interact with Regulatory Authorities as necessary for regulatory filings as well as Post-Market activities.

  • Keep abreast of EMEA regulations, guidance documents and standards, and prepare comments based on impact to product and business.

  • Identify regulatory requirements for new product and changes to existing products.

  • Develop regulatory affairs internal policies and procedures and provide internal trainings as and when required.

  • Participate in internal and external company regulatory/quality audits.

  • May be required to perform other related duties as required and/or assigned.

  • Has contact with all levels of company employees as well as frequent interactions with various external regulatory agencies, authorities, distributors, and customers.

Who are we looking for ?

  • 3 years of relevant RA experience and a Bachelor’s degree, ideally in Life Sciences, is required, as well as fluency in English, Fluency in French is desirable.

  • You have built up your RA experience within the in vitro Diagnostics industry – RA experience in genetic testing field is preferred, and have developed your expertise on the IVD Regulations.

  • We are looking for an independent, communicative and pro-active QARA Manager, who feels comfortable taking the lead in conducting the necessary QARA activities for the above-mentioned missions.​

SOFTSKILLS

Negotiation, Writing skills, Problem solving, Collaboration, Organization​

  • You have experience with working in multifunctional teams, in an international environment, remotely.

  • You are based in France or Spain, and ready for an onsite work experience or a remote one, with monthly trips to the headquarters, located in Montpellier, France (South of France).

  • The role is fulltime, comes with a competitive package, it’s a permanent role and it offers you the opportunity to become part of a young dynamic company with motivated and talented people having record-breaking  experience in serving science and healthcare!

You want to apply to this position ?

Send your resume and motivation letter to 

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