• Assure complaint records meet global requirements.

• Product complaint documentation, investigation, and review of all non-medical complaint content. Responsible for reviewing Medical complaints that involve a non-medical quality related problem. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.

• Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing and good documentation. Responsible that complaint files meet all regulatory requirements.

• Identification of potentially reportable events and notification to appropriate functional groups and management.

• Interface with Third Party Manufacturers, health care professionals, general public, internal customers, Abb Vie functional areas and regulatory agencies.

• Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.

• Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.

• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.

• Solid written/verbal communication and organizational skills.

• Knowledge and application of computer systems: MS word,excel

• Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.

• A Bachelor Degree required or 1-2 years of relevant work experience. (Preferred degree in technology or scientific background)

• 0-2 years’ work experience in a cGMP ( Good Manufacturing Practice) related industry or in a clinical setting (preferred).

• English B2+

At Abb Vie, we are committed to cultivating a work culture that promotes inclusion, diversity and personal growth. We recognize that our collective success is based on the individual well-being of our employees and that is why we have designed a benefits package with every aspect of their lives in mind.

Enhanced Health and Wellness Coverage: Our administrative staff has comprehensive medical and dental insurance, ensuring peace of mind for you and your loved ones.

Life Insurance: Secure your family's future with our life insurance policy.

Solidarity Association: Join a community focused on mutual aid and enjoy the benefits that come with being a member.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.