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.
Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.
Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
Our locations in **Scarborough, Maine** and **Lake Forest, IL** currently have an opportunity for an **Director Regulatory Affairs** . In this role, you will combine knowledge of scientific, regulatory and business issues to enable Infectious Disease Rapid Diagnostics products to be developed, manufactured and distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals in the IDDM Business Unit of Rapid Diagnostics.
**WHAT YOU'LL DO**
+ Strategic Planning-Identify need for new regulatory policies, processes and SOPs and approve them. Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture. Anticipate regulatory and related obstacles particularly in post-market surveillance and vigilance for the Rapid Diagnostics Infectious Disease products in Developed Markets.
+ Analyze and compare regulatory outcomes with initial Rapid Diagnostics product concepts, and recommend future strategies and actions. Develop global regulatory strategies and update based upon regulatory changes.
+ Anticipate emerging issues and develop solutions to address issues with other members of management and stakeholders. Develop business positions on regulatory risk-benefit approaches. Create and develop product positioning strategies based upon regulatory requirements.
+ Recruit, develop, and mentor regulatory professionals. Provide guidance for resource and development planning.. Individual is recognized as a key opinion leader and resource in regulatory affairs.
+ Must assure that all deadlines are met and provide effective leadership to regulatory post-market team. Administer /meet regulatory requirements to achieve excellent compliance status with no enforcement actions for IDDM business unit.
+ Participate in applicable trade association/industry working groups, largely in US and EU, to influence policy/rule-making in alignment with business strategies.
+ Premarket: 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 preapproval compliance activities are completed. Formulate company procedures to respond to regulatory authority queries.
+ 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 potential for findings of noncompliance. Identify and present option for risk mitigation to decision makers. Represent regulatory affairs in product recall and recall communication processes. 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**
+ BS Degree in Science ( biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
+ 7 Years of experience in a regulated industry
+ Communicate effectively verbally and in writing
+ Communicate with diverse audiences and personnel
+ Write and edit technical documents
+ Ability to prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and global regulatory agencies
+ Masters Degree in Technical area or MBA
+ 10 Years Regulatory Experience
+ Certifications such as RAC from the Regulatory Affairs Society
**WHAT WE OFFER**
At Abbott, you can have a good job that can grow into a great career. We offer:
+ **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.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com