Lawyer - Healthcare & Life Sciences

The role

A&L Goodbody is seeking a solicitor with 1-2 years of PQE to join its Healthcare & Life Sciences team in Dublin. This role focuses on advising clients on regulatory and compliance matters within the pharmaceutical and healthcare sectors.

What you'll do

• Advise Irish and international clients, as well as law firms, on EU and Irish pharmaceutical and healthcare regulatory frameworks and compliance matters across the healthcare, BioPharma, MedTech, animal health, food, and cosmetics sectors
• Advise on product classification, authorisation/certification, and regulatory requirements throughout the life cycle of each relevant product
• Advise on promotion, marketing, advertising and hospitality, regulatory requirements, prohibitions and restrictions, codes of practice of industry bodies (medicinal products and medical devices) regulatory guidance and advising on compliance and enforcement risks
• Advise on licensing, registration, certification and other requirements for manufacturing facilities and activities (MIA, controlled drugs, substances, APIs and chemicals), wholesale distribution facilities (WDA) and supply chain, brokers of medicinal products, laboratory facilities and compliance with GMP and GDP
• Advise on CE marking and the requirements of MDR and IVDR for all actors within the medical device supply chain
• Advise on market access, pricing and reimbursement, applications to the HSE under the Health (Pricing and Supply of Medical Goods) Act 2013 to gain reimbursement status for medicines, medical devices, special dietary foods etc. and on responding to the HSE in respect of price reviews, pricing strategies of the HSE Medicines Management Programme and other pricing initiatives and requests for price reductions
• Advise on the IPHA and MFI Framework Agreements for the Supply of Medicines to the HSE
• Respond to regulatory authorities, conformity assessment bodies, and governmental authorities including HPRA, HIQA, Department of Health, and the HSE, in respect of adverse findings on inspection, audit and in respect of reviews, inquiries and investigations
• Advise on Irish medical and healthcare law, telemedicine, digital health, and cross border healthcare
• Advise clients on the establishment of operations in Ireland and on the regulatory aspects of structuring and due diligence in corporate transactions in the regulated sectors
• Represent manufacturers and producers in the defence of product liability claims
• Advise on notifications to competent authorities, product withdrawal and recall in the regulated sectors

What we're looking for

Benefits

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