Regulatory Affairs Manager

12 Nov, 2020

Jobs

Regulatory Affairs Manager

Abbott Laboratories
Waukegan, IL

At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

 

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

 

As an individual contributor, the function of a Divisional Regulatory Affairs Manager is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.  The individual may execute tasks and play a consultative role by partnering across business functions. This person will manage the ARDx regulatory intelligence process and Divisional regulatory SOPs. This position may lead or support regulatory projects and acts independently to identify and resolve problems. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of programs.

 
  • Prepares robust regulatory applications to achieve departmental and organizational objectives
  • Lead strategic, complex projects impacting systemic business functions and processes
  • Serve as cross-divisional liaison on identified initiatives. lead project teams. serve as change agent
  • Drives cross functional alignment with issues that could have Regulatory ramifications
  • Builds strategic partnerships to further departmental and organizational objectives
  • Develop new regulatory policies, processes and SOPs and train key personnel on them. Develop, implement and manage Divisional Regulatory SOPs

Manages the ARDx regulatory intelligence process and system:

  • Monitor impact of changing regulations update internal stakeholders
  • Evaluate regulations/guidelines/standards changes for potential impact to ARDx. Properly interpret and apply regulatory requirements
  • Coordinate and manage assessment regulations/guidelines/standards changes
  • Identify emerging issues
  • Assesses proposed regulations and communicates new requirements to the organization
  • Monitor trade association positions for impact on company products
  • Plans and organizes project assignments of substantial variety and complexity
  • Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
  • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
  • Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments
  • Work is reviewed upon completion for adequacy in meeting objectives
  • Must function independently as a decisionmaker on regulatory issues, and must assure that deadlines are met
  • Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units
  • Understands business environment and relates extensive knowledge of internal and external activities to trends
 

 

BASIC QUALIFICATIONS | EDUCATION:
 
  • Bachelors Degree In a technical discipline (science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), engineering, or medical fieldshighly preferred
  • Minimum of 6 years of Regulatory experience; 8 years preferred
  • Experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area
  • 3+ years of experience in a regulated industry (e.g., medical products, nutritionals)
  • Note: Higher education may compensate for years of experience
  • Experience with US device and in vitro diagnostics regulations and submission
  • Experience with EU and other international medical device and in vitro diagnostics regulations and submissions
  • Ability to clearly, concisely and accurately convey complex concepts to various levels of staff; ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior; ability to work independently and in groups; interact with all levels of business professionals; demonstrated initiative and problem-solving skills; critical-thinking skills; ability to prioritize; -and strong organizational and project management skills
  • Experience working in a broader enterprise/cross-division business unit model preferred
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to leverage and/or engage others to accomplish projects
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Multitasks, prioritizes and meets deadlines in timely manner
  • Strong organizational and follow-up skills, as well as attention to detail
  • Ability to travel approximately 5%, including internationally
  • Ability to maintain regular and predictable attendance
  • Ability to work independently with no oversight
  • Ability to identify and solve problems in a strategic manner
  • Ability to manage complex projects
  • Ability to be proactive and not reactive, to anticipate changing business and regulatory environments
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
 

AN EQUAL OPPORTUNITY EMPLOYER, ABBOTT WELCOMES AND ENCOURAGES DIVERSITY IN OUR WORKFORCE.

 

We provide reasonable accommodation to qualified individuals with disabilities.

Learn more here

Job posted: 2020-11-12