JOB DESCRIPTION:The Opportunity This
Regulatory Affairs Manager - International Compliance Operations will work on-site at 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.
This
Regulatory Affairs Manager - International Compliance Operations will provide end to end support for the regulatory department to ensure efficient and compliant business processes and environment.
This position has responsibility for compliance activities for products and processes. The individual may execute tasks and play a consultative role by partnering across business functions, executing critical tasks and serving as a consultative partner to cross-functional teams. This new team member will identify emerging regulations, interpret them and clearly present implications to stakeholders, coordinate assessments, prioritize actions, and drive timely implementation to closure. Recommends, interprets and implements companywide policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Ensures employee compliance with such policies, practices and procedures and is responsible for continuous process improvement. Identify needed data, obtain it, and present it effectively to support product registrations worldwide. Assures that quality of services meets internal and external customer requirements.
What You'll Work On - Lead SOP / work instruction development and review
- Provide regulatory input to product lifecycle planning
- Periodically compare regulatory outcomes against initial product concepts and make data-driven recommendations on course-corrections.
- Assist in developing regional regulatory strategies and update them based on emerging regulations and standards.
- Identify market-access and cross-border regulatory considerations that could impact registrations, distribution, or timelines; proactively flag potential obstacles.
- Determine and communicate submission and approval requirements.
- Participate in risk benefit analysis to support compliance decisions and timelines.
- Assess the acceptability of documentation for gap assessments submitted.
- Lead Cross-Functional Team reviews; document minutes/decisions/action items; nominate change owners and target dates
- Coordinate change implementation via approved mechanisms; ensure completion by external compliance dates.
- Monitor impact of changing regulations on submission strategies.
- Assess external communications relative to regulations.
- 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.
- Provide regulatory input for product recalls and recall communications.
- Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders.
- Remain current on regulatory developments and industry trends; translate changes into practical guidance and training for impacted teams.
- Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
- Generate monthly metrics and present to Management as required
- Performs related functions and responsibilities, on occasion, as assigned.
- 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.
Required Qualifications - Bachelor's degree or an equivalent combination of education and work experience
- Minimum 8 years' experience in the medical device industry, with 5 of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II, and III medical devices.
- Ability to work effectively on project teams.
- Strong organizational skills with the ability to juggle multiple and competing priorities.
- Scientific writing experience is required.
- Working knowledge of QSR, ISO, and EN standards.
- Strong working knowledge of regulatory requirements for European community, Japan, Canada, and other countries.
- Strong verbal and written communications with ability to effectively communicate and present at multiple levels in the organization.
Preferred Qualifications - Bachelor's degree in medical, science or engineering related discipline.
- Advanced level degree (e.g., MS, PhD, PharmD, MBA) preferred
- Experience with FDA, ANVISA, TGA, NMPA, EU (MDR/IVDR) and other international medical device / drugs / pharma regulations and submissions.
- Experience with design controls in medical devices, IVDR, Pharma industries
- Experience with Veeva Vault, applying emerging technologies (e.g., AI assisted) for process improvements is a plus
- Experience building light automations / dashboards and presenting information to leadership
- Experience with managing small teams.
- Previous experience working in a highly matrixed and geographically diverse business environment
- Professional certifications a plus (e.g., RAC, PMP, Lean/Six Sigma)
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is $114,000.00 - $228,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Regulatory Operations
DIVISION:ADC Diabetes Care
LOCATION:United States > Alameda : 1360-1380 South Loop Road
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 15 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
