Regulatory Affairs Manager â APAC - Diabetes Care (on-site)
Regulatory Affairs Manager â APAC - Diabetes Care (on-site)
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$ 112000 - 224000
1 Vacancy
Job Description
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. Youll 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 bachelors 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. Were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were 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 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 Youll 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 cares 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
- Bachelors 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
- Bachelors 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:
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 on Facebook at and on Twitter @AbbottNews.Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$112000.00 $224000.00In 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 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: EEO is the Law link - Espanol: Experience:
Manager
Employment Type
Full-Time
Key Skills
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