As a leader of the Regulatory Affairs team, the candidate will contribute to the team’s success by providing leadership and support for the regulatory department to ensure efficient and compliant business processes in a medical device environment.
The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.
Required Skills & Abilities:
Execute and manage technical and scientific regulatory activities.
Must function independently as a decision-maker on regulatory issues and must assure that deadlines are met.
Effectively communicate, prepare and negotiate both internally and externally with various regulatory agencies.
Properly interpret and apply regulatory requirements.
Interfaces with a variety of management levels on significant matters, often requiring the coordination activity across organizational units.
May lead a cross-functional or cross-divisional project team.
Provides technical leadership to business units.
Knowledge of principles and requirements of promotion, advertising and labeling.
Knowledge of international treaties and regional, national, local and territorial trade requirements, agreements and considerations.
Knowledge of domestic and international regulatory guidelines, policies and regulations and ethical guidelines of the regulatory profession, clinical research and regulatory process.
Broad knowledge of various technical alternatives and their potential impact on the business.
Required education and experience:
Minimum 7 years’ relevant experience in a regulated industry.
Regulatory history, guidelines, policies, standards, practices, requirements and precedents.
Regulatory agency structure, processes and key personnel.
Principles and requirements of applicable product laws.
Submission/registration types and requirements.
GxPs (GCPs, GLPs, GMPs).
Principles and requirements of promotion, advertising and labelling.
Domestic and international regulatory guidelines, policies and regulations (including Europe).
Ethical guidelines of the regulatory profession, clinical research and regulatory process.
Drive gap analysis for new regulations.
Internal Number: 30872290
About Abbott Point of Care
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.