AddressAbbott 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 115,000 colleagues serve people in more than 160 countries.
For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
This Senior International Regulatory Project Analyst will work out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
As an individual contributor, the Project Analyst will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. This new team member may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. Additionally, may prepare and submit documentation needed for registration worldwide or may oversee such preparation.
WHAT YOU’LL DO
- Assist in SOP development and review
- Partner with cross-functional teams to consolidate the coordination, tracking and communication of regulatory submissions, priorities, roadmaps, milestones and status to key stakeholders
- Assist in developing regulatory information management system(s) to track regulatory submissions, license renewals etc.
- Define product roadmap as well as goals/metrics, as well as methodology and tools to measure these metrics
- Determine and communicate submission and approval requirements.
- Delivers on project timelines to achieve departmental and organizational objectives.
- Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
- Responsible for processes and issuance of Operational aspects in RA, such as Declaration of Conformities, CFGs/COEs, powers of attorney and regulatory letters; document authentication and legalization, etc.
- 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
- Maintain annual licenses, registrations, listings and patent information.
- Assist compliance with product post-marketing approval requirements.
- Review regulatory aspects of contracts.
- Assist with label development and review for compliance before release.
- Contribute to the development and functioning of the crisis/ issue management program.
- Ensure product safety issues and product associated events are reported to regulatory agencies.
EDUCATION AND EXPERIENCE YOU’LL BRING
Required:
- Bachelor’s degree
- 3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.
- Regulatory history, guidelines, policies, standards, practices, requirements and precedents
- Regulatory agency structure, processes and key personnel
- Principles and requirements of applicable product laws
- Submission/registration types and requirements GxPs (GCPs, GLPs, GMPs)
- Principles and requirements of promotion, advertising and labeling
- International treaties and regional, national, local and territorial trade requirements, agreements and considerations
- Domestic and International Regulatory guidelines, policies and regulations
- Ethical guidelines of the regulatory profession, clinical research and regulatory process
- Pay strong attention to detail, think analytically and organize and track complex information
- Manage projects and create project plans and timelines
- Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
- Has broad knowledge of various technical alternatives and their potential impact on the business
- Exercise good and ethical judgment within policy and regulations
- Use in-depth knowledge of business functions and cross group dependencies/ relationships
- Define regulatory strategy with supervision
- Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues
Preferred
- Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
- Certification is a plus (such as CAMP or PMP from PMI ®)
- 3-4 years of experience in in regulated industry in the roles of quality assurance, project management, research and development/support, operations, or related area.
- Advanced level degree
- Experience with design controls in medical device industry.
- Experience with working in developing regulatory information management systems.
- Experience with FDA, EU and other international medical device regulations and submissions.
- Proficient with Excel, PowerPoint, Power BI and presenting information to leadership
- Previous experience working in a highly matrixed and geographically diverse business environment
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
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. Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
- 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
The base pay for this position is $82,100.00 – $164,100.00. In specific locations, the pay range may vary from the range posted.
