IVDR Regulatory Affairs
& Quality Manager
3-years experience
On-site / remote
Negociable
At BIOSHARE SOLUTIONS, we aim to improve & accelerate patient diagnosis by offering new innovative solutions.
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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.
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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.
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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.
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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
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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.
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Structure the Company QMS and processes set-up to ensure Customers’ needs, suppliers’ conditions, products’ storage and transports conditions and traceability requirements are met.
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Collaborate with suppliers’ regulatory and quality teams to enable Marketing Authorization applications in targeted countries.
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Support sub-distributors and local agents with regulatory filings.
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Compile, review and maintain regulatory submissions / Marketing Authorizations (importer role) and review regulatory compliance of products for further distribution in Europe and abroad.
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Interact with Regulatory Authorities as necessary for regulatory filings as well as Post-Market activities.
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Keep abreast of EMEA regulations, guidance documents and standards, and prepare comments based on impact to product and business.
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Identify regulatory requirements for new product and changes to existing products.
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Develop regulatory affairs internal policies and procedures and provide internal trainings as and when required.
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Participate in internal and external company regulatory/quality audits.
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May be required to perform other related duties as required and/or assigned.
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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 ?
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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.
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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.
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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.​
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SOFTSKILLS
Negotiation, Writing skills, Problem solving, Collaboration, Organization​
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You have experience with working in multifunctional teams, in an international environment, remotely.
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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).
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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!