Analista de Operações Regulatorias Nível Sênior - Divisão de Dispositivos Médicos (MD) - São Paulo/SP

     

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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 will have access to:

• Career development with an international company where you can grow the career you dream of.
• Benefits such as Medical and Dental Assistance, Life Insurance, Private Pension Plan, Medication Subsidy, Discount on Abbott stock purchases, among others.
• 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.
• We offer flexible work policies that allow a healthy balance between personal and professional life
• We invest in the development of our employees through training and  growth opportunities
• We foster an environment where every voice is heard and valued

The Opportunity

This position is responsible for specialized level work assignments and/or analyses, evaluation, preparation, and management of global regulatory product releases and general support of global regulatory activities. Main responsibilities include Daily management of Global Product Release Authorization (PRA) activities allowing shipment of product to achieve departmental and organizational objectives.

What You’ll Do 

Serve as a regulatory representative, reviewing and analyzing GTS blocked orders, and coordinate activities to resolve issues.

Maintain a basic understanding of product lines and organize product information for internal procedures, reporting, quality plans, and audit needs.

Understand and utilize Windchill and other business systems for change control, documentation control, and other Regulatory Affairs interactions.

Complete other Regulatory Operations daily support tasks when assigned.

Represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, In-Country affiliates and IT.

Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

Minimum of 3 – 4 years experience in Regulatory Affairs, Regulatory Operations, Quality Assurance or related area in Medical Device industry

Bachelor's degree completed

Fluent in Portuguese and English, with strong verbal and written communication skills.

Experience with completing tasks in ERP system, SAP preferred.

Experience with Document Control Systems.

Knowledge with Medical Device Quality Management Systems (QMS) and Good Documentation Practice (GDP)

Proficient with MS Office suite (Word, Excel, Outlook)

Attention to detail and the ability to manage multiple tasks simultaneously.

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

Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

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

Multitasks, prioritizes and meets deadlines in timely manner.

Ability to collaborate and work cross functionally.

Strong organizational and follow-up skills, as well as attention to detail.

Ability to maintain regular and predictable attendance.

Strong problem solving skills and ability to think strategically and see the big picture.

Adaptable with the ability to switch priorities and accomplish all tasks.

Process oriented.

Apply Now

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 and @AbbottGlobal.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

MD Medical Devices

        

LOCATION:

Brazil > Sao Paulo : Rua Itapeva, 538-5 ao 8 andares B

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable