A global technology company is seeking a regulatory attorney with over 8 years of legal experience in healthcare or life sciences. The role focuses on developing regulatory strategies in the UK, advising on legal issues impacting healthcare technologies, and collaborating with various internal teams. The ideal candidate will possess strong knowledge of medical devices regulations and excellent communication and project management skills.
Qualifikationen
8+ years of legal experience in healthcare or life sciences.
6+ years of relevant work experience in healthcare or life sciences regulatory work.
Strong domain in Medical Devices / Medical Devices Software Regulation.
Aufgaben
Develop and implement health regulatory strategy in the UK.
Advise on legal regulatory issues affecting Oracle products.
Collaborate with other teams to progress regulatory goals.
Kenntnisse
Regulatory attorney
Knowledge of healthcare tech and life sciences regulatory requirements
Project management skills
Excellent communication skills
Problem-solving abilities
Interpersonal skills
Ausbildung
Bachelor of Law or equivalent
Advanced degree
Jobbeschreibung
Responsibilities
Assist in developing and implementing the health and life sciences regulatory strategy in the region, with a particular focus on the United Kingdom, advise, and educate Oracle Life Sciences and Health senior executives on health regulatory requirements and policy initiatives.
Advise on legal regulatory issues impacting our customers' use of Oracle products with a focus on electronic health records technologies, artificial intelligence and machine learning, software as a medical device, life sciences clinical research, real world data, privacy and security.
Advise on the regulatory implications of commercial transactions to enable the fast and efficient completion of commercial transactions in a manner that is viewed positively by our customers and partners.
Work with the health and life sciences regulatory affairs team to monitor, assess, and advise on relevant regulatory developments and their impact on Oracle Health and Life Sciences products and services.
Participate in and represent Oracle with various regulatory bodies and agencies to implement Oracle's health policy initiatives in the EMEA region, with emphasis on the UK.
Design and implement regulatory strategies to ensure compliance with software as a medical devices regulations in jurisdictions in the region, with emphasis on UK.
Formulate strategies to implement patient safety priorities with product teams, leadership, customers, and regulatory authorities as appropriate and promote a patient safety culture.
Participate in developing regulatory strategies for evolving AI/ML regulations relevant to health and life sciences industries and participate in and comment on various public policy initiatives relating to AI/ML.
Design and implement regulatory strategies to ensure compliance with medical device laws, AI regulations, data privacy and health data regulations, fraud and abuse laws, and other relevant legal regulatory requirements in the region, with emphasis on UK.
Participate in developing a corporate-wide regulatory framework and program to meet the needs of Oracle customers subject to strict regulatory requirements with a focus on the healthcare/health science industries.
Input into policy initiatives in the health and life sciences regulatory space in the EMEA region and globally.
Collaborate cross-functionally with other teams, including internal product development, cloud operations, compliance, security, business practices, marketing, and sales teams, to help progress the regulatory program goals and initiatives.
Maintain high credibility, independence, integrity, confidentiality, and trust.
Qualifications
Regulatory attorney (Bachelor of Law or equivalent) with +8 years of legal experience in healthcare or life sciences.
Minimum qualifications include an advanced degree with 6+ years of relevant work experience in healthcare or life sciences regulatory work.
Knowledge of healthcare tech and life sciences regulatory requirements in Europe, and particularly the United Kingdom.
Strong domain in Medical Devices / Medical Devices Software Regulation.
Professional demeanor, confidence, and innovation with the ability to effectively communicate with senior executives and clients.
Excellent writing, analysis, negotiation, and partnership skills.
Problem solver with a creative, innovative approach and strong decision‑making abilities.
Outstanding project management and interpersonal skills.
Exceptional business orientation and ability to balance legal considerations with commercial priorities.
Ability to perform in a fast‑paced and continually evolving business environment.
Leadership Competencies
Performance, drive, and execution
Collaboration
Communicating for impact
Inspirational leadership
Competitive edge
Change agility
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