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 103,000 colleagues serve people in more than 160 countries.Abbott Point of Care is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable, and cost-effective. Our i-STAT System is an advanced, portable diagnostic tool that provides real-time, lab-quality results within minutes to accelerate patient-care decision-making. The i-STAT System has the industry’s most comprehensive menu of tests in a single, with-patient platform, including tests for blood gases, electrolytes, chemistries, coagulation, hematology, glucose, and cardiac markers. By delivering lab-quality results in minutes, our i-STAT System fosters a collaborative, patient-centered environment while driving improved operational performance.Our Princeton, NJ division has an opportunity for a Regulatory Affairs Project Manager . 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 individual 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 compliance with applicable Corporate and Divisional Policies and procedures.
Properly interpret and apply regulatory requirements and provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products achieving business goals.
Anticipate and identify regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
Monitor impact of changing regulations on submission strategies and update internal stakeholders.
Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management.
Provide strategic input and technical guidance on regulatory analytical and clinical requirements to development teams.
Evaluate risk of and provide regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions.
Determine submission documentation and approval requirements for submission filing
Define regulatory strategy, as well as develop and maintain regulatory plans.
Manage technical and scientific regulatory activities.
Lead functional groups to compile; prepare; review and submit regulatory submission to authorities
Identify regulatory risks on regulatory applications and communicate to key stakeholders.
Effectively communicate, prepare, and negotiate with both internally cross functional teams and externally with various regulatory authorities during the development and review process to ensure submission approval.
Monitor applications under regulatory review and 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.
Review and approve advertising and promotional items to ensure regulatory compliance
Review and approve labeling materials to ensure regulatory compliance.
Review and assess proposed preclinical; clinical, manufacturing and other type of changes for regulatory filing strategies.
Ensure compliance with product post marketing approval requirements.
Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events.
Function independently as a decision-maker on regulatory issues; and must assure that deadlines are met.
Mentor other regulatory professionals.
May lead cross divisional projects.
EDUCATION AND EXPERIENCE YOU’LL BRINGRequired
Bachelor’s degree in a technical discipline (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, math, engineering, or medical field)
10 years’ work experience with at least 5 years in regulatory.
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.
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.
Master’s in a technical area highly preferred; PhD is helpful
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Experience working in a broader enterprise/cross-division business unit model
Experience with IVDs
WHAT WE OFFERAt 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 at http://www.abbottbenefits.com/pages/candidate.aspxFollow 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 at http://www.abbott.com/ , on Facebook at www.facebook.com/Abbott and on Twitter @Abbott News and @AbbottGlobal.An Equal Opportunity EmployerAbbot 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