Director, Regulatory Affairs

Director, Regulatory Affairs

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Working at Abbott:

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity:

The function of a Director, Regulatory Affairs is to combine scientific, regulatory, and business expertise to ensure that products developed, manufactured, or distributed comply with applicable regulatory requirements. Additionally, the Director may develop and supervise regulatory professionals. This role has division-level influence and is generally recognized as a key opinion leader and expert resource, both within Abbott and externally. The Director may influence evolving regulations and guidance, interface with regulatory agencies and trade associations, and provide executive management with regulatory metrics, insights, and strategic recommendations.

What You'll Work On:

• Responsible for compliance with applicable Corporate and Divisional policies and procedures.
• Strategic Planning: Identify the need for new regulatory policies, processes, and SOPs, and approve them. Develop and advance the organization's policies and procedures for regulatory affairs and compliance to establish a compliant culture. Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
• Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions. Develop global regulatory strategies and update them based on regulatory changes.
• Set quality and accuracy standards. Anticipate emerging issues and develop solutions to address them.
• Develop solutions to address issues with other members of management and stakeholders.
• Develop corporate positions on regulatory risk-benefit. Create and develop product positioning strategies based on regulatory requirements.
• Recruit, develop, and mentor regulatory professionals. Provide guidance for resource and development planning.
• Participate in applicable trade association and industry working groups to influence policy and rule-making in alignment with business strategies.

Premarket:

• Communicate application progress to internal stakeholders.
• Create and file global regulatory submissions, including U.S. (Biologics License Applications [BLA], PMA, 510(k)), European Notified Body, Health Canada, Japan, and other international market submissions.
• Negotiate with regulatory authorities during the development and review process to ensure submission approval.
• Provide strategic input and technical guidance on regulatory requirements to development teams.
• Ensure pre-approval compliance activities are completed.

Postmarket:

• Oversee regulatory aspects of business relationships to ensure compliance and protect corporate interests.
• Provide regulatory input for follow-up to inspections and audits to minimize the potential for findings of noncompliance.
• Identify and present options for risk mitigation to decision-makers.
• Ensure adverse events are reported to regulatory agencies and internal stakeholders.
• Manage processes involved in maintaining annual licenses, registrations, listings, and other regulatory information.
• Ensure compliance with product postmarketing approval requirements.
• Review and approve advertising and promotional materials to ensure regulatory compliance.
• Must assure that all deadlines are met and provide effective leadership without direct authority. Completed work is checked through consultation and agreement with others rather than through formal review by a superior.
• Work is performed without appreciable direction and requires significant latitude in determining the technical objectives of assignments. Assignments are often self-initiated; determines and pursues courses of action necessary to obtain desired results.
• Recognized as a key opinion leader and resource in regulatory affairs.

Influence/Leadership:

• Develops, communicates, and builds consensus for operating goals that are aligned with divisional and corporate objectives.
• Provides leadership by communicating and providing guidance toward achieving department, division, and/or corporate objectives.
• Interfaces with a variety of management levels, including senior management, on significant matters, often requiring coordination of activities across organizational units.
• May lead a project team or initiative within the department or across functions/divisions.
• Provides technical leadership to business units.
• Acts as a mentor to less experienced staff, both within and outside the department/division.
• Exercises independent judgment.
• Leads assigned departments by developing, communicating, and building consensus for goals and programs that support division, business unit, and company objectives.
• May participate in or lead external industry working groups to influence advocacy in alignment with business strategies.

Planning/Organization:

• Creates mid- to long-range plans to carry out objectives established by top management.
• Develops and manages a budget for one or more departments to meet organizational goals.
• Forecasts future departmental or group needs, including human and material resources and capital expenditures.
• Determines and establishes organizational structure and supervisory relationships, subject to top management approval.

Required Qualifications:

• Bachelor's Degree in science, math, engineering, medical fields.
• Minimum 7-10 years of experience in a regulated industry (e.g., medical products, nutritionals), including regulatory affairs or related functions such as quality assurance, R&D, scientific affairs, or operations.
• Experience supporting new product development programs from development through commercialization.
• Experience leading regulatory submissions/registrations and managing interactions with regulatory agencies in domestic and international markets.
• Strong knowledge of regulatory guidelines, policies, standards, requirements, applicable product laws, submission pathways, and GxPs (GCPs, GLPs, GMPs).
• Ability to define and execute regulatory strategies, including obtaining product licensure worldwide.
• Excellent written and verbal communication skills, including technical writing and presenting to senior management and regulatory agencies.
• Ability to influence and negotiate regulatory issues with cross-functional teams and regulatory authorities.
• Strong project management skills, with the ability to manage multiple priorities, create project plans and timelines, and track complex information.
• Strong analytical, problem-solving, and risk assessment capabilities.
• Ability to lead cross-functional teams in the development of data and documentation required for regulatory submissions.

Preferred Qualifications:

• Master's Degree in technical area or M.B.A.
• Proven experience leading global IVD regulatory submissions, including FDA 510(k)s; experience with BLA submissions preferred.
• Executive presence with strong influencing, negotiation, and people leadership skills.
• Ability to develop innovative processes and drive improvements with broad organizational impact.
• Broad understanding of technical alternatives and their potential business impact.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).