We are seeking an ambitious Solicitor, 1-2 years PQE, to join our Healthcare Life Sciences Team focusing on the areas of regulatory compliance, and product liability.
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.
We provide our clients with comprehensive advice on a wide range of issues, including: 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 **** 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.
Transactions and Establishment We also 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 Product Recall and Product Liability On the contentious side the successful candidate will represent manufacturers and producers in the defence of product liability claims.
We also advise on notifications to competent authorities, product withdrawal and recall in the regulated sectors supported by the Healthcare and Life Sciences team.
Requirements Demonstrates sectoral interest and relevant experience in their career to date - as a trainee and as a newly 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.
Note this is not a medical negligence role.
Benefits A competitive remuneration package Access to the firm's marquee training and development programmes, delivered through the ALG School of Business and Law Discretionary performance bonus Pension and health insurance contribution, wellbeing contribution, life assurance, subsidised gym, restaurant and coffee shop.
Hybrid working policy The firm A L Goodbody (ALG) is a leading Irish law firm with five international offices in Dublin, Belfast, London, New York and San Francisco.
There are currently 120 partners and over 900 employees.
The strong international and domestic business community in Ireland forms a valuable part of the ALG client base.
ALG is incredibly proud to be recognised as the leading Irish law firm in the Chambers and Partners Europe **** Guide with the highest number of Band 1 practice area rankings.
ALG is also ranked as a 'top tier' law firm in The Legal 500 EMEA Guide **** and the IFLR**** Guide ****.
The firm is consistently ranked number one in the Irish market and on a European level.
A sample of other recent notable awards include: Awarded the prestigious Company of the Year award at the National Diversity Inclusion Awards **** hosted by the Irish Centre for Diversity.
Recognised by Mergermarket as the #1 M A legal advisor in Ireland by deal volume for **** Winner of the Best Client Service Award by the Lawyer European Awards Future of Legal Services Innovation Award winners **** Awarded the Investors in Diversity Silver Mark in **** by the Irish Centre for Diversity Most Popular Graduate Recruiter in Law **** by GradIreland (for 13 consecutive years) Law firm of the year – Republic of Ireland **** at The Lawyer European Awards Irish Law Firm of the Year **** at the Chambers Europe Awards One of the top 50 most innovative law firms in Europe **** by the Financial Times Best client support **** by the Managing Partners Forum Business Working Responsibly Mark **** ALG has a reputation for leading the way in continuously developing its service to clients and internally to its business.
This is delivered through the use of new processes, ways of working, innovative use of technology and marketing-leading business service teams.