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
ABOUT ABBOTT DIAGNOSTICS:
The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.
Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.
Our location in Lake Forest, IL currently has an opportunity for a Regulatory Affairs Project Manager – Clinical Chemistry. The function of a Regulatory Affairs Project Manager is to combine knowledge of scientific; regulatory and business issues to enable products that are developed; manufactured or distributed to meet required legislation. The Project Manager has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed; obtain these data and ensure that they are effectively presented for the registration of products worldwide.
WHAT YOU’LL DO
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Develop new regulatory policies; processes and SOPs and train key personnel on them
- Evaluate regulatory risks of division policies; processes; procedures
- Provide regulatory input to product lifecycle planning
- Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
- Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes
- Assist in regulatory due diligence for potential and new acquisitions
- Utilize technical regulatory skills to propose strategies on complex issues
- Determine submission and approval requirements
- Monitor trade association positions for impact on company products
- Anticipate and identify regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
- Recruit; develop and mentor regulatory professionals
- Assess the acceptability of quality; preclinical and clinical documentation for submission filing
Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
- Compile; prepare; review and submit regulatory submission to authorities
- Monitor impact of changing regulations on submission strategies and update internal stakeholders
Monitor applications under regulatory review
- Communicate application progress to internal stakeholders and ensure external communications meet regulations
- Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
- Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies
- Negotiate and interact 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
- Manage and execute preapproval compliance activities
- Oversee 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
- Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events
- Actively contribute to the development and functioning of the crisis/issue management program
- Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies
- Report adverse events to regulatory agencies and internal stakeholders
- Provide regulatory input for product recalls and recall communications
- Function independently as a decision-maker on regulatory issues; and must assure that deadlines are met
EDUCATION AND EXPERIENCE YOU’LL BRING
- Bachelor’s degree (or equivalent); Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred.
- 2-5 years’ experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- 4-5 years’ experience in a regulated industry (e.g., medical products, nutritionals).
- 6-8 years’ work experience
- Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
- 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 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.
- Experience working in a broader enterprise/cross-division business unit model
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: 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.