Regulatory Affairs Manager – APAC - Diabetes Care

Regulatory Jobs; Alameda (CA); On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

Excellent retirement plan

Tuition reimbursement

FreeU education benefit

Recognized as a great place to work

Job summary

Abbott is seeking a Regulatory Affairs Manager – APAC in Alameda, CA to lead a regulatory team and ensure compliant processes for Diabetes Care products. You will develop global regulatory strategies, collaborate with cross-functional teams, and support preparations for APAC submissions.

The role requires strong communication skills, regulatory experience in medical devices or diagnostics, and ability to navigate APAC standards. On-site at Alameda with travel as needed.

Qualifications

• Bachelor's degree or an equivalent combination of education and experience.
• 4-5 years’ experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years in regulatory preferred but may consider related areas.
• Strong verbal and written communications with ability to communicate at multiple levels in the organization.

Responsibilities

• Manage a team of regulatory specialists.
• Develop and advance regulatory policy and procedures for compliance.
• Represent Regulatory Affairs on cross-functional teams for APAC projects.
• Propose strategies on complex regulatory issues.
• Compile, prepare, and review submissions to APAC regulators for medical devices/IVD.
• Provide guidance on regulatory authority queries and design changes impact.

Skills

Regulatory leadership

APAC regulatory

Regulatory submissions

Communication skills

Education

Bachelor's degree

Master's degree or MBA preferred

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in 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 - 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.

The Opportunity

ThisRegulatory Affairs Manager – APACposition 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.

ThisRegulatory Affairs Manager – APACposition will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment. In this role, you will combine knowledge of scientific, regulatory, and business issues to enable products to meet required legislation in the APAC region. You will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region.

What You’ll Work On

• Managing a team of regulatory specialists
• Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture.
• Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on regulatory requirements in the APAC region for Diabetes care’s projects.
• Utilize technical regulatory skills to propose strategies on complex issues
• Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the APAC region.
• Provide strategic input and technical guidance on regulatory authority queries.
• Evaluate proposed design and manufacturing changes for regulatory impact and implement required regulatory actions.
• Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
• Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
• Ensure compliance with product post marketing approval requirements
• Review product labeling and promotional materials to ensure compliance with relevant regulatory requirements.
• Provide regulatory support for internal and external audits.

Required Qualifications

• Bachelor's Degree OR an equivalent combination of education and experience.
• 4-5 years’ experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• 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; PhD in a technical are or law.
• 5+ years’ experience in regulatory affairs.
• Supervisory experience.
• Scientific writing experience.
• Working knowledge of ISO and EN standards, as well as country-specific standards in the APAC region.
• Strong working knowledge of regulatory requirements for the APAC region.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).

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

$114,000.00 – $228,000.00

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

WORK SHIFT:

Standard

TRAVEL:

Yes, 20 % 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)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf