Regulatory Affairs Director, Medical Devices

Abbott; United States; On-site; USD 190,000 - 260,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO plan

Strong retirement plan

Tuition reimbursement

FreeU education benefit

Global employer recognition

Diversity and inclusion awards

Job summary

Abbott in Alameda, CA is seeking an Associate Director, Regulatory Affairs to shape regulatory strategies across the product lifecycle in the Diabetes Care division. This on-site role requires leading and developing high-performing teams, interfacing with agencies, and guiding executive leadership with strategic metrics.

You will drive regulatory planning, anticipate obstacles, and oversee submissions, labeling reviews, and compliance across global markets, enabling patient access to Abbott's

Qualifications

• Bachelor's degree in a relevant field.
• 5-7 years' experience in a regulated industry (e.g., medical products).
• 5-7 years' experience in regulatory preferred but may consider quality assurance, research and development/support, scientific a

Responsibilities

• Develop global regulatory strategies for product development and planning throughout the product lifecycle.
• Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
• Provide technical leadership and strategic input on complex issues and to business units.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Develop and communicate a vision for the organizational unit assigned.
• Create project plans and timelines.
• Lead functional groups in the development of relevant data to complete a regulatory submission.
• Write and edit technical documents.
• Recruit, develop and manage regulatory professionals.
• Evaluate performance of and assists in career development planning for subordinates.
• Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
• Negotiate with regulatory authorities during the development and review process to ensure submission approval.
• Review and approve labeling to ensure compliance.
• Monitor emerging issues and identify solutions.
• Negotiate internally and externally with regulatory agencies.
• Identify need for new regulatory policies, processes and SOPs and approve them.
• Evaluate regulatory risks of corporate policies.
• Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
• Ensure compliance with product post-marketing approval requirements.
• Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events.
• Actively contribute to the development and functioning of the crisis/issue management program
• Analyze product-associated problems and develop proposals for solutions.
• Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies.
• Provide regulatory input for product recalls and recall communications.

Skills

Regulatory leadership

Global regulatory strategy

Stakeholder management

Strategic planning

Education

Bachelor's degree

Job description

Abbott in Alameda, CA is seeking an Associate Director, Regulatory Affairs to shape regulatory strategies across the product lifecycle in the Diabetes Care division. This on-site role requires leading and developing high-performing teams, interfacing with agencies, and guiding executive leadership with strategic metrics.

You will drive regulatory planning, anticipate obstacles, and oversee submissions, labeling reviews, and compliance across global markets, enabling patient access to Abbott's