Abbott · 3 hours ago
Manager Regulatory Affairs
Lake Forest, IL
Full-time
Onsite
Mid, Senior Level
$99K/yr - $199K/yr
5+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The Manager, Regulatory Affairs role focuses on ensuring that products meet regulatory requirements and involves developing regulatory strategies, managing a team, and representing the company during audits.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
Develop and implement regulatory strategies to support product development and commercialization. Oversee preparation and submission of product registrations, progress reports, supplements, amendments, and periodic reports. Experience with US FDA and IVDR are a plus
Manage and mentor regulatory staff, fostering a collaborative and high-performing team. Provide regulatory guidance and support to cross-functional teams
Promote a commercially aware compliance culture. Ensure adherence to harmonized standards and evolving regulations while balancing business objectives
Act as delegate for Management Review when required. Serve as the primary regulatory liaison throughout the product lifecycle, including interactions with regulatory agencies to expedite approvals
Participate in product planning, regulatory strategy development, and risk management activities. Provide expert advice on manufacturing changes, line extensions, technical labeling, and regulatory interpretations
Oversee regulatory aspects of the change control process. Ensure timely and compliant execution of product changes
Lead the Advertising and Promotional Review function within Regulatory Affairs. Collaborate with Commercial and Marketing teams to ensure compliant promotional materials
Implement and manage UDI requirements across applicable products
Support field action reporting activities as needed. Represent Regulatory Affairs during internal and external audits
Proactively analyze regulatory feedback, identify challenges, and develop solutions to facilitate approvals and maintain compliance
Qualification
Required
Bachelor's degree in Science, Math, Engineering, or medical fields
Minimum 5 years in a regulated industry (e.g. medical products, in vitro diagnostics). Regulatory experience preferred but may consider quality assurance, research and development, scientific affairs, operations, or related area
Up to 15% travel required
Preferred
Master's degree in technical area or MBA
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)
Benefits
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
Excellent retirement savings plan with a high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
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