Administrative Office Specialist - Sao Paulo, Brasil - MicroPort Orthopedics

Descrição

At MicroPort, we relentlessly strive to master every detail of our medical solutions with the purpose of prolonging and reshaping the lives of patients everywhere.

We welcome motivated and talented people who want to join our dynamic and inclusive company, working together to deliver meaningful medical breakthroughs.

In order to accomplish this, we hold true to our core values of Quality, Integrity, Accountability, Efficiency, Innovation, Aspiration, Dedication & Collaboration.

Come and join Team MicroPort


Why You'll Love MicroPort
You will find our team atmosphere challenging and rewarding. In addition to working with a world-class team, receiving a competitive base salary and bonus opportunities, our U.S.

employees also enjoy the following benefits:

Medical, Dental, Vision, Maternity Leave, Life Insurance, Short-Term Disability, Long-Term Disability, Bereavement, 401(k) (up to 4% match with vesting from day 1), PTO (Starting at 18 days each year), Paid Holidays (10 each year), Employee Assistance Program, Education more At MicroPort, we care about our employees and encourage them to make healthy lifestyle choices and embrace wellness opportunities to maintain their very best health and wellbeing.

Overall Summary

As an Administrative Office Specialist, you will play a role in supporting regulatory affairs, commercial and marketing for Latin America based in the Brazilian office in the division of orthopedic devices.

In this role, you will be able to provide support and expertise as part of the organization using knowledge of Brazil regulatory requirements and paths to support the achievement of business objectives.

This position is office-based.


Your duties will include

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RA/QA

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1. Assist with the Brazilian Quality Management System maintenance including Quality Manual and other SOPs per local inspection

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• Ensure that local quality standards are met and ongoing updates based on annual inspections going forward.
• Participate in internal audits.

2. Prepare Class I and III submissions for manager review

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3. Receives Distributor inquiries, check items and prepare Import Authorization Letters for RA Manager to review and sign

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4. Support with post-market activities as necessary

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• Receive Product Complaint information and forward to ANVISA and MPO.

5. Help with creation of local Brazilian Labeling (Secondary eIFU & Label added to product)

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• Support customer requests for printed IFUs.

6. Help maintain license information for Regulatory Release of Instruments

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• Update licenses with new or removed instruments for amendments as surgical techniques updated.

Commercial & MKT

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1. Support with operational duties related to Commercial and Marketing

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2. Compliance Documents (MedEd/WCS) - SOVs RSOVs

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3. Compliance Documents (MedEd/WCS) - Industry events

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4. Registration Surgeons in the Platform (HCP System)

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5. Support with the system FTI Comply (Distributor Contracts)

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6. Maintain all documentation necessary according to Compliance requirements

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Other Duties

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• Prepare and send invoices to finance.
• All MicroPort ́s office expenses for office lease, phone, internet, office supplies, etc.
• Maintain adequate Office Supplies, Cleaning Supplies, etc.
• Handle general inquiries from Distributors (answer calls about products, questions about product quality, etc.).
• Support on events, congress, workshops (organization etc.)
• Support customer requests and receives general inquiries from distributors in Latin America.
• Contact with Customer Service in the USA issues/questions with orders.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice

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About You

We might be a great match if you have

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• Advanced English, Spanish is a plus.
• Written and verbal communication, organization, time management, attention to detail and independence.
• Flexibility and agility to accommodate constant project changes and time constraints.
• Demonstrated ability to solve problems with limited or no supervision.
• Demonstrated effective interpersonal, teamwork, and communication skills required.

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YOUR EDUCATION

_Required:
_Undergraduate completed in any field.


_ Preferred:
_Bachelor's degree in a science field is preferred.


YOUR EXPERIENCE
Minimum of 1 year of professional experience required