Regulatory Operations Director

Abbott Laboratories
Published
October 5, 2020
Location
Alameda, CA
Job Type

Description

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 107,000 colleagues serve people in more than 160 countries

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.  Abbott Diabetes Care (ADC) – home of the FreeStyle Libre Glucose Monitoring System – has opened up a new Regulatory Operations Director position to support our rapid growth in Alameda, CA.  We are looking for a seasoned regulatory leader ideally with experience in global regulatory operations, advertising & promotional review (ad promo), and pre-market and post-market activities in the medical device industry. Duties will consist of a combination of regulatory operations and submissions work, but primarily operations. The Regulatory Operations Director will be responsible for oversight of ongoing improvement projects and will work closely with Abbott corporate as well as our existing Regulatory Affairs Directors at ADC.

WHAT YOU’LL DO 

The function of the Regulatory Operations Director 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 division level influence and is generally considered a key opinion leader and an expert resource both within Abbott and externally. The individual may influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information. The individual may plan, direct, coordinate and control the regulatory affairs activities related to products worldwide.  Responsibilities for this role may include:

  • Identify need for new regulatory policies, processes and SOPs and approve them.

  • Develop and advance the organizations policy 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 based upon regulatory changes.

  • Conduct regulatory due diligence for potential and new acquisitions and advise management.

  • Sets quality and accuracy standards

  • Anticipate emerging issues and develop solutions to 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 upon regulatory requirements.

  • Integrate regulatory considerations into the corporations global product entry and exit strategy.

  • Recruit, develop, and mentor regulatory professionals.

  • Provide guidance for resource and development planning.

  • Participate in applicable trade association/industry working groups to influence policy/rule making in alignment with business strategies.

  • Communicate application progress to internal stakeholders.

  • 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.

  • Formulate company procedures to respond to regulatory authority queries.

  • Oversee regulatory aspects of business relationships to ensure compliance and protect corporate interests.

  • Ensure a system is in place to manage access to information requests.

  • Provide regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance.

  • Ensure crisis management program implemented and functioning

  • Identify and present option for risk mitigation to decision makers.

  • Represent regulatory affairs in product recall and recall communication process.

  • Ensure adverse events are reported to regulatory agencies and internal stakeholders.

  • Manage processes involved with maintaining annual licenses, registrations, listings and patent information.

  • Ensure compliance with product post-marketing approval requirements.

  • Review and approve advertising and promotional items to ensure regulatory compliance.

  • Review and approve publicly disseminated information to minimize regulatory exposure; review product claims, and preserve confidentiality of applicable product information

EDUCATION AND EXPERIENCE YOU’LL BRING 

Required:

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

  • 7-10 years experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.

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 Affairs Professionals Society.)

  • 7-10 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

  • Strong knowledge of: 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 labeling.  

  • International treaties and regional, national, local and territorial trade requirements, agreements and considerations.

  • Domestic and international regulatory guidelines, policies and regulations.

  • Ethical guidelines of the regulatory profession, clinical research and regulatory process.

  • Ability to 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 and participate in political lobbying.

  • Demonstrate effective use of negotiation skills to resolve regulatory issues in cross-functional teams to ensure completion of project tasks.

  • Effectively negotiate regulatory agreements with global regulatory agencies.

  • Negotiate regulatory and scientific issues with management.

  • Manage projects. Create project plans and timelines. Must be able to juggle multiple and competing priorities and think analytically with good problem solving skills.

  • Plan and implement most appropriate strategy to obtain product licensure in least amount of time worldwide.

  • Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.

  • Counsel management on regulatory policies so as to maximize income, minimize competition, and minimize risk to business.

  • Direct and manage the preparation of technical strategic regulatory documentation for agency submission.

  • Understanding of 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 (Manufacturing roles only) 

  • Production areas that are clean, well-lit and temperature-controlled (Manufacturing roles only) 

  • 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:  http://www.abbottbenefits.com/pages/candidate.aspx 

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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