RA Specialist, Latin America

Há 4 dias

Barueri, Brasil Intuitive Surgical Tempo inteiro
Company DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.Job Description

Primary Function of Position

The RA Specialist oversees Latin America Countries, supporting distributors in this region by evaluating medical device/facility registration and changes notifications, to determine and execute registration strategy and ensuring compliance of marketing material

Essential Job Duties

This position has responsibility and authority for:

  • Elaborating Product Registration Dossier for hybrid countries, like Brazil and Mexico
  • Preparing submission documentation with the assistance of the distributor, where required
  • Answering Additional Inquiries from the Ministries of Health or any other entity involved on product registration or other licenses/certificates
  • Managing registration processes with consultants, when necessary
  • Controlling Licenses Renewals
  • Assessing Global Regulatory Assessments (GRAs/MRPs) related to product, facility and/or process changes
  • Managing assessments related to the GRA/MRP and submission processes in Agile, Product Registration database (PRdb) and BOX drive locations
  • Requesting translation for product registration and other certification provided by the countries that are not in English
  • Update trackers in order to keep the processes information updated
  • Managing communications with in country health authority
  • Reviewing periodically the regulatory requirements by region / country (Regulatory Surveillance Process)
  • Updating internal Work Instructions according changes in the countries requirements
  • Communicating submission status with commercial and marketing teams
  • Assisting and supporting other employees, teams and field personnel as necessary
  • Supporting INMETRO and ANATEL certification
  • Participating on Association meetings
  • Participating on trainings (QMS, technical and product)
  • Managing specific projects for process improvements
  • Other regulatory tasks and projects may be assigned as necessary
Qualifications

Required Skills and Experience

  • Fluent in written and spoken English is required.
  • Advanced in written and spoken Spanish is required.
  • Demonstrate strong written and verbal communication skills.
  • Strong computer skills (Excel, Word, PowerPoint, database)
  • Minimum 4+ years of experience in medical device companies, with experience or exposure in the following areas:
  • Product Registration in the most relevant Latin America countries, like Brazil, Mexico, Ecuador, Peru, Colombia, Argentina and Panama
  • INMETRO and ANATEL Certification
  • Change notification assessments
  • Regulatory Surveillance Assessments

Required Education and Training

  • Graduated in engineering, life science, or equivalent

Working Conditions

  • Hybrid: Barueri/SP (minimum on site: 2 days per week), 10% of the time travelling

Preferred Skills and Experience

  • General understanding of Lati America Requirements for Medical Devices Registration.
  • Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.Efficient independent worker with ability to focus.
  • Attention to detail.
  • Demonstrate cross functional communication skills in email and in person.
  • Excellent organizational and analytical skills
  • Ability to handle and manage workload independently.
  • Prioritize numerous activities in a rapid paced environment.
  • Contribute to team-oriented tasks.
  • Strong analytical skills
  • Strong interpersonal and decision-making skills.
Additional Information

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Shift: Day
Travel: 10% of the time

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