Abbott

Principal Regulatory Affairs Specialist - APAC - Diabetes Care (on-site)

Abbott • $100K — $200K *
Alameda, CA 94501In-Person
Healthcare
5 - 7 years of experience
Reposted 6 days ago
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in a Scientific discipline like Chemistry or Biology
  • Experience in regulatory submissions for Pharmaceuticals or medical devices
  • Familiarity with 21 CFR 820 and ISO 13485
  • Strong verbal and written communication skills
  • Proven experience in regulatory affairs preferred (5+ years)
  • Fluency in Chinese is a plus

Responsibilities

  • Lead strategic planning for regulatory registration and product release
  • Oversee processes to maintain product compliance and registration
  • Engage with regulatory authorities to facilitate submission approvals
  • Coordinate with cross-functional teams to meet product release requirements
  • Develop and maintain processes supporting efficient product release
  • Evaluate product issues and provide compliant solutions
  • Hire and develop a diverse regulatory affairs team

Benefits

  • Career development with an international company
  • Free medical coverage under the Health Investment Plan
  • Excellent retirement savings plan with strong employer contributions
  • Tuition reimbursement and student debt relief programs
  • Recognition as a top employer for diversity and workplace culture
Full Job Description
JOB DESCRIPTION:

The Opportunity

This Principal Regulatory Affairs Specialist - APAC position 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 Principal Regulatory Affairs Specialist position is responsible for leading strategic planning as well as developing and deploying innovative solutions to ensure timely regulatory registration and release of products for distribution into specific geographies in the growing Asia Pacific (APAC) market.

What You'll Work On
  • Executes and ensures timely product registration and release for distribution.
    • As the Regulatory Affairs functional lead, oversee and optimize processes and team efforts to obtain and maintain product registration/approval, completion of activities to support release authorization and ensure compliant release of product to specified geographies.
    • Drive strategic engagement with regulatory authorities during the development and review process, ensuring clear communication of complex technical concepts and resolutions to regulatory challenges to facilitate understanding and secure submission approval.
    • Coordinate with cross functional teams including but not limited to: global Regulatory Affairs (e.g., APAC, CALA, EMEAP and US), Commercial, Marketing / PLC, Supply Planning, Customer Service, Quality, R&D, Operations, etc. to ensure all internal and external requirements are met prior to product release. Manage multiple programs independently, identifying risk areas and escalating issues as appropriate.
  • Product release process ownership.
    • Develops and refines processes and tools to support efficient and controlled product release.
    • Responsible for developing, maintaining, and ensuring compliance with applicable Corporate and Divisional policies and procedures.
  • Product registration, release authorization and release planning.
    • Provide Regulatory input to product lifecycle planning and project strategy based upon regulatory changes
    • Monitor for and guide team in responding to emerging regulatory issues
  • Evaluate product issues and develop informed, compliant solutions aligned with the regulatory requirements of the specific geography.
  • Acts as a liaison with other departments, e.g., Quality, R&D, Legal, Operations, Marketing and Clinical Affairs, for major initiatives.
  • Hires, retains, and develops a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with applicable U.S. Food and Drug Administration (FDA) and international regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains professional and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.


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).
  • Strong verbal and written communications with ability to effectively communicate and present at multiple levels in the organization.


Preferred Qualifications
  • Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
  • Masters in technical area or MBA; Doctorate in a technical area or law.
  • 5+ years' experience in regulatory affairs.
  • Scientific writing experience.
  • Solid understanding of the EU Medical Device Regulation (MDR - Regulation (EU) 2017/745) and/or the In Vitro Diagnostic Medical Device Regulation (IVDR - Regulation (EU) 2017/746)
  • Experience working within an ISO 13485-certified Quality Management System
  • Proven international registration experience, ideally with a focus on Asia Pacific markets
  • Fluency in Chinese is highly desirable
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).


Apply Now

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
$100,000.00 - $200,000.00
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, 5 % 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)

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.

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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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