Regulatory Affairs, Project Manager
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.
REGULATORY AFFAIRS, PROJECT MANAGER
POMONA/ SAN DIEGO/ CHICAGO/ REMOTE
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 location in POMONA/ SAN DIEGO/ CHICAGO/ REMOTE currently has an opportunity for a REGULATORY AFFAIRS, PROJECT MANAGER. This role is part of the Regulatory Affairs department with direct responsibility for developing regulatory plans with a high level of complexity. Plans and prepares documentation for international and domestic product registrations for new and modified products. Leads project submissions for regulatory approvals 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. Interacts with governmental regulatory agencies, other third-party accrediting bodies, and US trade associations.
WHAT YOU’LL DO
- Provides regulatory support for diagnostic product development and commercial diagnostic products
- Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the US and internationally
- Researches scientific and regulatory information to write, edit, and review submission documents
- Prepares robust regulatory applications to achieve departmental and organizational objectives
- Works with governmental regulatory agencies and other third-party accrediting bodies
- Maintains approvals/licenses/authorizations for existing marketing authorizations
- Ensures accuracy of US registration and device listing
- Adds and maintains information contained in the Global Regulatory Information Database
- Provides regulatory leadership to development teams:
- Provides global strategic input (including all feasible alternatives and associated risks)
- Drives cross-functional alignment with issues that could have regulatory ramifications
- Interacts and builds partnerships with competent authorities (FDA, and other regulatory agencies)
- Builds strategic partnerships to further departmental and organizational objectives.
- Provides leadership and guidance (including training) to other members of the RA staff
- Reviews device labeling for compliance with the applicable US and international regulations
- Reviews of product and manufacturing changes for compliance with applicable regulations (Change Control)
- Provides recommendations on manufacturing, and analytical and clinical study plans for regulatory compliance
- Reviews validation reports for regulatory submission soundness
- Reviews advertising and promotion to ensure compliance with product claims
- Keeps informed of global regulatory information; prepares impact assessments and communicates new requirements to the organization
- Contributes to management review for new or revised regulations and/or other quality system activities
- Has awareness of device defects that may occur in their area of responsibility, including product design, verification, and validation, manufacturing, and testing activities
- Develops internal procedures and tools
- Assists with audits and inspections, as needed
- May represent Abbott on US trade associations
- Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS) 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
- Carries out duties in compliance with established business policies
- Demonstrates commitment to the development, implementation, and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Other duties as assigned, according to the changing needs of the business.
EDUCATION AND EXPERIENCE YOU’LL BRING
- Bachelor’s degree (BS/BA) in any scientific field
- 5 years of experience in a regulated industry
- Minimum of 3 years’ experience in Regulatory Affairs with progressively increasing responsibilities
- Experience with 510(k) notification or Pre-submissions and US device regulations and/or experience with EU and other international medical device regulations and submissions
- Strong knowledge of quality systems in a regulated manufacturing environment
- Five plus years in an IVD or medical device manufacturing environment
- RAC Certificate preferred
- Good knowledge of business models, resource planning, and budgeting
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
- Production areas that are clean, well-lit, and temperature-controlled
- 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 a 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.
Learn more here
Job posted: 2021-07-18