Abbott

Senior Regulatory Affairs Specialist

Abbott • $110K — $130K *
Santa Clara, CA 95054In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • 3-4 years in a regulated industry (e.g., medical products, nutritionals)
  • 2-3 years of regulatory experience preferred, but other related experiences considered
  • Certification in regulatory affairs (e.g., RAC) is a plus
  • Working knowledge of EU MDR and US/EU medical device submissions
  • Experience in supporting internal and external inspections
  • Ability to work in a cross-functional, matrixed environment
  • Experience with continuous improvement initiatives

Responsibilities

  • Manage and prepare global filings for new product registrations and changes
  • Assist in developing and reviewing Standard Operating Procedures (SOPs)
  • Provide regulatory insights for product lifecycle planning
  • Advise company SMEs on regulatory requirements for products and procedures
  • Track global regulatory changes and partner with GSI for information dissemination

Benefits

  • Medical and Prescription Drug Plans
  • Dental Plan
  • Vision Plan
  • Health Savings Account
  • Flexible Spending Accounts
  • Supplemental Life Insurance
  • Short and Long Term Disability
  • Critical Illness and Accident Insurance
  • Legal, ID Fraud, and Pet Insurance services
  • 401(k)
Full Job Description
Job Title: Senior Regulatory Affairs Specialist

Location: Santa Clara, CA 95054

Duration: 12 Months

Work Arrangement: 100% Onsite

Description:

Senior Regulatory Affairs Specialist (International)

The Senior Regulatory Affairs Specialist (International) is to 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. The individual may assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

Years Experience:
  • Minimum 3 years 3-4 years experience in a regulated industry (e.g., medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Skills:
  • Have working knowledge in EU MDR
  • Have working knowledge in Regulatory Change Assessment in
  • Have working knowledge in US and EU medical device submissions
  • Have experience supporting internal and external inspections
  • Work cross-functionally and in a matrixed environment
  • Have experience with continuous improvement activities

Education:
  • Bachelors Degree (± 16 years) Related field OR an equivalent combination of education and work experience
  • Masters Degree (± 18 years) In Regulatory Affairs preferred and may be used in lieu of direct regulatory experience.

Duties:
  • Manage and oversee the preparation of high-quality global filings for sustaining changes and new product registration. Manage rest of world (all geographies outside the US and EU) submissions.
  • Strategic Planning: 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.
  • Assist company SME's to interpret existing or new regulatory requirements for company products and procedures, labeling, marketing projects, testing and record keeping. May anticipate and advise on future regulatory trends and direction and recommend preemptive approaches for company regulatory.
  • Proactively track global regulatory requirement changes and work with Global Strategic Intelligence (GSI) team to disseminate the information to all team members.

Consultants Eligible Benefits Upon Waiting Period:
  • Medical and Prescription Drug Plans
  • Dental Plan
  • Vision Plan
  • Health Savings Account (for High Deductible Health Plans)
  • Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
  • Supplemental Life Insurance
  • Short Term Disability (coverage varies by state)
  • Long Term Disability
  • Critical Illness, Hospital coverage, Accident Insurance
  • MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
  • 401(k)

  • Published on 25 Sep 2026, 5:09 PM

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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