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Regulatory Affairs Specialist â APAC

3 months ago

Alameda, United States Abbott Laboratories Full time

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. Youâll also have access to:

  • Career development with an international company where you can grow the career you dream of.
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
  • 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 bachelorâs 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. Thatâs why weâre 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. Weâre revolutionizing the way people monitor their glucose levels with our new sensing technology.

The Opportunity

We are presently hiring for a Regulatory Affairs Specialist, as part of the Regulatory Affairs Asia Pacific (APAC) team, on-site at our Diabetes Care Division HQ location in Alameda, CA. As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.  The individual may execute tasks and exercise influence generally at the middle management level.  The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.

What Youâll Work On

  • Perform regulatory activities as below for APAC countries.
  • Determine and communicate submission and approval requirements.
  • Monitor applications under regulatory review.
  • Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory submission strategies.
  • Assist in the preparation and review of regulatory submissions to authorities.
  • Assist compliance with product post-marketing approval requirements.
  • Assist in the review of advertising and promotional items.
  • Assist with label development and review for compliance before release.
  • Submit and review change controls to determine the level of change and consequent submission requirements.
  • Ensure product safety issues and product-associated events are reported to regulatory agencies.
  • Individuals may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
  • Participates in developing less experienced staff by setting an example, providing guidance, and offering counsel.
  • Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of given assignments. May lead a departmental project team.
  • Establishes and cultivates an extensive network of support to facilitate completion of assignments.
  • Participates in determining goals and objectives for projects.
  • Influences middle management on technical or business solutions.
  • Exercises judgment in selecting innovative, practical methods to achieve problem resolution.

Required Qualifications

  • Bachelor's degree or an equivalent combination of education and work experience  
  • Minimum of 2 yearsâ experience in a regulated industry (e.g., medical products, nutritionals, pharma, food). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
  • Communicate effectively verbally and in writing.  Communicate with diverse audiences and personnel.  Write and edit technical documents.
  • Work with cross-functional teams.  Work with people from various disciplines and cultures.
  • Write and edit technical documents. 
  • Negotiate internally. 
  • Pay strong attention to detail.
  • Manage projects. Create project plans and timelines.
  • Think analytically and critically.
  • Organize and track complex information.
  • Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Apply business and regulatory ethical standards.

Preferred Qualifications

  • Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields. 
  • Masterâs degree
  • 1+ year of Regulatory Affairs experience within Medical Devices is strongly preferred.
  • Prefer some knowledge of 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; Domestic and international regulatory guidelines, policies and regulations;  Ethical guidelines of the regulatory profession, clinical research and regulatory process.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)  

Apply Now

* 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.

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 $65,900.00 â $131,900.00. In specific locations, the pay range may vary from the range posted.