Healthcare Regulatory Solicitor – Pharma, MedTech, EU/IRL

Consulting Vanuatu Limited; Dublin; Vor Ort; EUR 86.000 - 105.000; Vollzeit

Benefits dieser Stelle

Bonus

Pension

Annual reviews

Bike to work

Gym

Travel tax incentives

Zusammenfassung

Consulting Vanuatu Limited's client, a well-known expanding law firm, seeks a Solicitor with 1-3 years PQE to join the Healthcare Team. You will advise on EU and Irish regulatory frameworks across healthcare, BioPharma, MedTech, animal health, food and cosmetics.

Salary to €95k with bonus and comprehensive benefits. The role requires experience in healthcare regulatory matters; you will work with Irish and international clients and law firms on product classification, licensing, market access,

Qualifikationen

• Experience in healthcare and life sciences regulatory matters.
• Strong academic credentials and legal ability in healthcare/life sciences.
• Ability to research thoroughly and communicate advice clearly.

Aufgaben

• Advise on product classification, authorisation, certification, and regulatory requirements throughout the product lifecycle.
• Provide guidance on marketing, promotion, advertising, hospitality, and industry codes of practice for medicinal products and medical devices.
• Advise on compliance with regulatory prohibitions, restrictions, and enforcement risks.
• Provide advice on licensing, registration, and certification for manufacturing facilities (including MIA, controlled drugs, substances, APIs, and chemicals).
• Counsel on wholesale distribution facilities (WDA), supply chains, brokers of medicinal products, laboratory facilities, and compliance with GMP and GDP standards.
• Offer advice on CE marking and the requirements of MDR and IVDR for actors within the medical device supply chain.
• Advise on market access, pricing, and reimbursement, including applications to the HSE under the Health (Pricing and Supply of Medical Goods) Act 2013 for reimbursement status for medicines, medical devices, and special dietary foods.
• Provide support on price reviews, pricing strategies, and the HSE Medicines Management Programme.
• Respond to regulatory authorities such as HPRA, HIQA, the Department of Health, and the HSE regarding adverse findings, inspections, audits, reviews, inquiries, and investigations.
• Advise on telemedicine, digital health, and cross-border healthcare in Ireland.
• Collaborate with corporate teams on establishing operations in Ireland and advising on regulatory aspects of structuring and due diligence in corporate transactions within the regulated sectors supported by the Healthcare and Life Sciences team.
• Defend manufacturers and producers in product liability claims.
• Advise on notifications to competent authorities and guide clients through product withdrawal and recall processes in regulated sectors.

Kenntnisse

Healthcare regulatory

Pharma law

Regulatory compliance

Legal research

Clear communicator

Team collaboration

Jobbeschreibung

Consulting Vanuatu Limited's client, a well-known expanding law firm, seeks a Solicitor with 1-3 years PQE to join the Healthcare Team. You will advise on EU and Irish regulatory frameworks across healthcare, BioPharma, MedTech, animal health, food and cosmetics.

Salary to €95k with bonus and comprehensive benefits. The role requires experience in healthcare regulatory matters; you will work with Irish and international clients and law firms on product classification, licensing, market access,