Senior Regulatory Affairs Manager at Abbott

Shanghai, China

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

HealthcareIndustries

Requirements

Bachelor’s degree or above
Above 10 years of working experience
Minimum 2 to 4 years of relevant RA (Regulatory Affairs) management experience
Good English speaking, written, and communication skills

Responsibilities

Lead and complete regulatory registrations to ensure shipment of product within the Asia Pacific region
Be responsible for registration projects for the designated countries in the region
Solve requests for additional information and issues/questions from regulatory agencies and governments to meet submission requirements
Ensure that new registration projects are scheduled and that expected schedules are achieved
Ensure the renewal of licenses and change applications are submitted on time
Provide regulatory intelligence updates for regulations, standards, and guidance documents to ensure organizational compliance
Provide explanations for regulatory changes and applicable training to global or local cross-functional groups if necessary
Communicate with cross-functional teams such as Quality Assurance, R&D, Marketing, Operations, and others to ensure complete and accurate information for submissions and communicate regulatory requirements
Assist in ensuring that registration procedures and SOPs are clear, concise, and aligned with current practices and requirements
Provide related regulatory support to other company personnel
Develop and maintain good relationships with related authorization agencies and relevant industry associations to build advocacy

Skills

Regulatory Affairs

Product Registration

Regulatory Compliance

Asia Pacific Regulations

License Renewal

Change Applications

Regulatory Intelligence

Cross-Functional Communication

SOP Development

Agency Liaison

English Communication

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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