Healthcare Lawyer

A&L Goodbody LLP; Dublin; Hybrid; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Competitive remuneration package

Access to training and development programmes

Discretionary performance bonus

Pension and health insurance contribution

Wellbeing contribution

Subsidised gym

Restaurant and coffee shop

Job summary

A leading law firm in Dublin is seeking an ambitious Solicitor with 1-2 years of post-qualification experience to join their Healthcare & Life Sciences Team. This role offers the opportunity to advise on EU and Irish regulatory frameworks across various sectors, including pharmaceuticals and healthcare. Responsibilities include providing compliance advice, handling regulatory requirements, and assisting with market access for medical products. Benefits include a competitive remuneration package, trainings, and a hybrid working policy.

Qualifications

• Demonstrates sectoral interest and relevant experience (trainee and newly qualified solicitor).
• Ability to deal with legal concepts and technical complexity.
• Comfortable working within challenging deadlines.

Responsibilities

• Provide regulatory and compliance advisory on product classification and requirements.
• Advise on marketing and promotional regulatory requirements.
• Assist with licensing and compliance for manufacturing facilities.
• Provide CE marking guidance and advice on medical device regulations.
• Assist with market access and pricing applications to HSE.
• Respond to regulatory authorities regarding inspections and audits.
• Provide advice on medical and healthcare law issues.

Skills

Regulatory and compliance advisory

Legal analysis

Clear communication

Research and attention to detail

Education

Excellent academic achievements and technical legal ability

Job description

Overview

We are seeking an ambitious Solicitor, 1-2 years PQE, to join our Healthcare & Life Sciences Team focusing on 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.

Responsibilities

• Provide regulatory and compliance advisory on product classification, authorisation/certification and regulatory requirements throughout the life cycle of relevant products.
• Advise on promotion, marketing, advertising and hospitality, regulatory requirements, prohibitions and restrictions, codes of practice of industry bodies (medicinal products and medical devices) and compliance and enforcement risks.
• Assist with 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 GMP/GDP compliance.
• Provide CE marking guidance and advice on MDR/IVDR for all actors within the medical device supply chain.
• Assist with 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 and devices, respond to HSE pricing reviews, and advise on IPHA and MFI Framework Agreements for the supply of medicines to the HSE.
• Respond to regulatory authorities, conformity assessment bodies, and governmental authorities (e.g., HPRA, HIQA, Department of Health, HSE) in respect of adverse findings, inspections, audits, reviews, inquiries and investigations.
• Provide Irish medical and healthcare law advice, including telemedicine, digital health, and cross-border healthcare.

Qualifications

• Demonstrates sectoral interest and relevant experience in their career to date (trainee and newly qualified solicitor).
• Excellent academic achievements and technical legal ability in areas relevant to the Healthcare and Life Sciences Team.
• Ability to deal with legal concepts and technical complexity; thorough research with attention to detail; clear and concise communication; ability to construct clear advice for clients.
• Comfortable working within challenging deadlines and 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 training and development programmes
• Discretionary performance bonus
• Pension and health insurance contribution, wellbeing contribution, life assurance, subsidised gym, restaurant and coffee shop
• Hybrid working policy