Abbott Director, Regulatory Affairs in Pomona, California
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.
Director, Regulatory Affairs
Lake Forest, IL OR Pomona, CA
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, nutritional and branded generic medicines. Our 107,000 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 location in Lake Forest, IL, or Pomona, CA currently has an opportunity for a Director, Regulatory Affairs is within our Toxicology business unit. This role has direct responsibility for managing the Toxicology Regulatory Affairs Department in North America (and other regions as applicable). This role enables the business objectives of Toxicology BU by implementing and managing regulatory affairs activities and establishes processes that ensure timely product registrations, product availability, and post-market support that satisfies customer requirements . This role sits in our Rapid Diagnostics Division, and Toxicology Business Unit.
WHAT YOU’LL DO
Ensures the establishment and maintenance of regulatory affairs processes for U.S. registrations and product development, international registrations, and post-market–sustaining activities, including:
Monitoring new and changing regulations and guidance and disseminating information to stakeholders.
Identification of regulatory trends and provision of key regulatory intelligence updates on a global basis.
Preparation of documentation for international and domestic product registrations for new and modified products.
Evaluation of information to develop strategies and shape future regulations and guidance, as well as interact with governmental regulatory agencies, other third-party accrediting bodies, and US trade associations.
Represents Abbott on US trade associations and contributes to trade positions
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.
Compiles and publishes all material required for submissions, license renewals, and annual registrations.
Works with governmental regulatory agencies and other third-party accrediting bodies.
Maintains approvals/licenses/authorizations for existing marketing authorizations.
Adds and maintains information contained in the Global Regulatory Information Database.
Provides recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance.
Reviews validation reports for regulatory submission soundness.
Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
Reviews advertising and promotion to ensure compliance with product claims.
Ensures consistent guidance and interpretation of regulations, standards, and regulatory intelligence for application to design and development planning, registration planning, and impact assessments.
Provides leadership and management of the department.
Conducts recruitment, onboarding, and training for …
Engages with Business Unit (BU) quality leads and other Abbott BU and division regulatory affairs leads to align on and establish policy.
Establishes and manages the department budget.
Ensures continuous improvement in alignment with industry best practices.
Reports on department metrics to senior leadership.
Contributes to management review for new or revised regulations and/or other quality system activities.
Manages performance of staff towards department and Company goals, including feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance, etc.
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification, and validation, manufacturing, and testing activities
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; build productive internal/external working relationships
Carries out duties in compliance with established business policies
Act as Person Responsible for Regulatory Compliance (PRRC) in regards to:
Ensuring the technical documentation and the EU declaration of conformities are drawn up and kept up-to-date.
Ensuring in the case of investigational devices, a signed statement that the device conforms to the general safety and performance requirements according to IVDR is issued.
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 biological science
Minimum of ten years of experience in Regulatory Affairs, US and international
Five plus years in an IVD or medical device manufacturing environment.
Must be knowledgeable of federal and other regulations, e.g. QSRs, ISO 13485, CMDR, IVDR, MDR.
Strong knowledge of international regulations
Strong knowledge of quality systems in a regulated manufacturing environment.
Good knowledge of business models, resource planning, and budgeting.
Ability to work with staff at all levels of the organization, global teams including time-zone flexibility.
Excellent presentation, oral and written communication skills, computer skills with MS Office applications.
Skilled in using computers, specifically MS Word, Powerpoint, Excel.
Process orientated, detailed, logical, analytical, meticulous, and highly organized, able to analyze data and implement solutions.
Adaptable and willing to take on multiple new tasks and responsibilities while managing and prioritizing multiple tasks within a dynamic work environment.
Strong management skills with proven leadership and team-building skills.
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 ( Manufacturing roles only )
Production areas that are clean, well-lit, and temperature-controlled ( Manufacturing roles only )
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.
Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott , and Twitter @AbbottNews and @AbbottGlobal.
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
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