The successful candidate will 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.
Note this is not a medical negligence role.
Responsibilities:
- Product classification, authorisation/certification and regulatory requirements throughout the life cycle of each relevant product.
- 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.
- 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.
- CE marking and advice on the requirements of MDR and IVDR for all actors within the medical device supply chain.
- 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. Advising on the IPHA and MFI Framework Agreements for the Supply of Medicines to the HSE.
- Responding 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.
- Irish medical and healthcare law, telemedicine, digital health, and cross border healthcare.
- Work closely with the firm’s corporate teams advising 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 supported by the Healthcare and Life Sciences team
- On the contentious side the successful candidate will 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 supported by the Healthcare and Life Sciences team.
- Demonstrates sectoral interest and relevant experience in their career to date - as a trainee and as a qualified solicitor.
- Possesses excellent academic achievements and technical legal ability in areas relevant to the sectors supported by the Healthcare and Life Sciences Team and role.
- Deals with legal concepts and technical complexity comfortably.
- Conducts research thoroughly, accurately and demonstrates strong and consistent attention to detail.
- Is a clear and concise communicator.
- Constructs clear advice for clients responding to client’s requirements in a timely way.
- Is comfortable working within challenging deadlines to meet client requirements.
- Is comfortable working collaboratively with the Healthcare and Life Sciences Team and across the firm.
