Associate 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 109,000 colleagues serve people in more than 160 countries.

About Abbott

For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

Our location in Santa Clara, CA or Temecula, CA, currently has an opportunity for an Associate Director Regulatory Affairs.

WHAT YOU'LL DO:

PRIMARY FUNCTION:

The function of an Associate Director Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, Manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has department level influence and is generally recognized as an expert resource both within Abbott and externally. The individual may comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information. The individual may ensure that data are identified, obtained and effectively presented for the registration of products worldwide.

ACCOUNTABILITY / SCOPE / BUDGET:

Scope is division wide regulatory direction for product development and support to develop most rapid successful strategy for approval to market products to meet business objectives; administer /meet regulatory requirements to achieve excellent compliance status with no enforcement actions. Must assure that all deadlines are met and provide effective leadership without direct authority. Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Completed work is reviewed from a relatively long term perspective for desired results. Individual is recognized as an industry expert and resource in regulatory affairs. Develops, communicates, and builds consensus for operating goals that are in alignment with the division. Provides leadership by communicating and providing guidance towards achieving department objectives. Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units. May lead a project team or initiative within department or cross functions/divisions. Provides technical leadership to business units. Acts as a mentor to less experienced staff. Exercises judgment independently. Creates immediate to long range plans to carry out objectives established by top management. Develops and calculates a budget for a department or group to meet organizational goals. Forecasts future departmental needs including human and material resources and capital expenditures. Assignments are expressed in the form of objectives Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. Consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.

Individual manages group or small department providing direction and guidance to exempt and non-exempt personnel who exercise some latitude and independence in their assignments. Individual evaluates performance of and assists in career development planning for subordinates.

MAJOR RESPONSIBILITIES:

Core job responsibilities for this function may include:
  • Provide strategic guidance for product development and planning 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 based upon regulatory changes
  • Conduct regulatory due diligence for potential and new acquisitions and advise management
  • Utilize technical regulatory skills to propose strategies on complex issues
  • Monitor emerging issues and identify solutions Monitor trade association positions for impact on company products
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
  • Recruit, develop and manage regulatory professionals Approve regulatory filing strategies based upon proposed preclinical, clinical and manufacturing changes
  • Monitor impact of changing regulations on submission strategies and update internal stakeholders
  • Communicate application progress to internal stakeholders
  • Monitor and submit applicable reports and responses to regulatory authorities
  • 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
  • Oversee processes involved with maintaining annual licenses and registrations
  • Ensure compliance with product post marketing approval requirements
  • Review and approve labeling to ensure compliance
  • Review and approve required reports, supplemental submissions and other post marketing commitments
  • Review change controls for level of change and consequent regulatory notification
  • Identify and present option for risk mitigation to decision makers
  • Represent regulatory affairs in product recall and recall communication process


EDUCATION AND EXPERIENCE YOU'LL BRING:

MINIMUM EDUCATION

Bachelors' degree (or equivalent); Bachelors' degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.

** M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.**Certification is a plus (such as RAC from the Regulatory promotion, adv

Affairs Professionals Society.)

MINIMUM TRAINING & EXPERIENCE REQUIRED:

5-7 years of experience in regulatory affairs (Note: Higher education may compensate for years of experience) that includes:
  • Submission/registration types and requirements GxPs (GCPs, GLPs, GMPs)
  • Principles and requirements of labeling
  • Domestic and international regulatory guidelines, policies and regulations
  • Ethical guidelines of the regulatory profession, clinical research and regulatory process
  • Communicate effectively verbally and in writing
  • Communicate with diverse audiences and personnel
  • Work with cross functional teams
  • Work with people from various disciplines and cultures
  • Write and edit technical documents
  • Prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and global regulatory agencies
  • Negotiate internally and externally with regulatory agencies
  • Plan and conduct meetings
  • Demonstrate effective use of negotiation skills to resolve regulatory issues in cross functional teams to ensure completion of project tasks
  • Manage projects
  • Create project plans and timelines
  • Juggle multiple and competing priorities
  • Think analytically with good problem solving skills
  • Organize and track complex information
  • Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
  • Has broad knowledge of various technical alternatives and their potential impact on the business
  • Exercise good and ethical judgment within policy and regulations
  • Define regulatory strategy
  • Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues
  • Investigate and solve problems that impact work processes and personnel within or across units or departments
  • Develop and communicate a vision for the organizational unit assigned
  • Lead functional groups in the development of relevant data to complete a regulatory submission
  • Monitor costs of projects and of human and material resources within a department or unit
  • Monitor companywide indicators such as market share and profitability
  • Monitor external environment in area of technical or professional responsibility
  • Understand reimbursement


WHAT WE OFFER :

At Abbott, you can have a good job that can grow into a great career. We offer:

•A fast-paced work environment where your safety is our priority

•Training and career development, with onboarding programs for new employees and tuition assistance

•Financial security through competitive compensation, incentives and retirement plans

•Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

•Paid time off

•401(k) retirement savings with a generous company match

•The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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