Principal International Regulatory Product Specialist - Diabetes Care (on-site)
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 - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
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 more effectively and comfortably, 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. 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 Principal Specialist will provide subject-matter expertise and hands-on execution for the regulatory department to ensure efficient and compliant business processes and environment. The individual execute tasks and play a consultative role by partnering across business functions. This new team member assists in identifying emerging regulations, interpreting their impact, aid in developing gap assessments and assigned actions to closure in coordination with owners. Additionally, ensuring that these emerging items are effectively presented to different stakeholders across the organization. This role has department/group-level influence; it may lead cross-functional project teams. Additionally, may prepare and submit documentation needed for registration worldwide or oversee such preparation.
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 in order 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 for 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 e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
- Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices.
- Experience of 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 (such as 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 / drugs / pharma regulations and submissions.
- Experience with design controls in medical devices, IVDR, Pharma industries
- Proficient with Excel and PowerPoint and presenting information to leadership; experience with Veeva Vault and dashboarding/automation (e.g., reminders/escalations) 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.
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. 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.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
$100,000.00 - $200,000.00In specific locations, the pay range may vary from the range posted.