Principal International Regulatory Product Specialist - Diabetes Care (on-site)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life‑changing technologies spans diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit. At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why 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. The Opportunity This Principal International Regulatory Operations Specialist will work on‑site at our Alameda, CA location in the Diabetes Care Division. As an individual contributor, you will provide subject‑matter expertise and hands‑on execution for the regulatory department to ensure efficient and compliant business processes and environment. You will execute tasks and play a consultative role by partnering across business functions, assist in identifying emerging regulations, interpret their impact, aid in developing gap assessments and assigned actions to closure in coordination with owners, and ensure these emerging items are effectively presented to stakeholders. What You’ll Work On Contribute regulatory input to product and process change plans triggered by new or revised regulations/standards; ensure affected dossiers, technical documentation, labeling, and procedures are updated on time. Coordinate with regional RA to update submission strategies and registration maintenance in response to regulatory changes. Establish and maintain a structured horizon‑scanning log for priority jurisdictions; publish concise impact assessments with owner, due date, and evidence links. Lead or co‑lead cross‑functional working sessions to document decisions, actions, and closure evidence, track progress against external compliance dates. Assist in SOP development and review. Provide regulatory input to product lifecycle planning. Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes. Understand, investigate, and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context to assess regulatory implications for approval. Determine market access issues to anticipate regulatory obstacles. Determine and communicate submission and approval requirements. Participate in risk benefit analysis for regulatory compliance. Assess the acceptability of documentation and deliver clear gap assessments with closure plans and evidence. Monitor impact of changing regulations on submission strategies. Maintain annual licenses, registrations, listings (as applicable). Assist compliance with product post‑marketing approval requirements. 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. Support knowledge sharing by facilitating training and providing guidance to peers on new/updated requirements. Required Qualifications Bachelor’s Degree in Scientific discipline (Chemistry, Life Sciences, Biology or equivalent vocational qualifications). Experience in regulatory submissions for Pharmaceutical, In‑vitro diagnostic devices and/or medical devices. Experience working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC). Preferred Qualifications Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields. Certification is a plus (e.g., RAC from the Regulatory Affairs Professionals Society). 2‑3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, engineering, scientific affairs, operations, or related area. Experience collaborating across QA, R&D, Clinical, Labeling, and Operations; may consider strong cross‑functional experience with demonstrable regulatory change leadership. Advanced level degree. Experience with EU and other international medical device/drug/pharma regulations and submissions. Experience with design controls in medical devices, IVDR, Pharma industries. Proficient with Excel, PowerPoint, and presenting information to leadership; experience with Veeva Vault and dashboarding/automation is a plus. 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. Apply Now Learn more about our health and wellness benefits: Abbott is an Equal Opportunity Employer, committed to employee diversity. Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. 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JOB FAMILY:

Regulatory Operations

DIVISION:

ADC Diabetes Care

LOCATION:

United States > Alameda: 2901 Harbor Bay Parkway

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % 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) Base Pay: $100,000.00 – $200,000.00 In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr Dormont Manufacturing Co