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Regulatory Affairs Specialist

Req ID:  2979

Working Location: FLORIDA, MIAMI 

 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

This position will act as the subject matter expert (SME) for Olympus product registrations in Latin American Region executing the activities required to obtain the product registrations and approvals needed to support the business strategy. The incumbent will be responsible to assure accurate product registration execution.  He/She will further initiate and perform routine and periodic assessment activities appropriate to the various Latin American Markets to ensure regulatory compliance is maintained.

Job Duties

* Acts as the regulatory affairs representative on new product registration and/or RA lifecycle management for assigned product portfolio within the Latin American Region.


* Evaluates the regulatory environment and provide internal advice throughout the product lifecycle for marketed devices to ensure product compliance.


* Anticipates regulatory obstacles and emerging issues throughout the product/registration lifecycle and develops solutions.


* Requests, collects and reviews technical/legal documentation from Legal Manufacturers assuring its adequacy to the registration requirements in Latin America.


* Prepares, submits and coordinates with RA Consultants or Distributors regulatory submissions for new products and product changes as required in accordance with established timelines and submission dates to ensure timely approvals while in compliance with regulatory requirements and guidelines.


* Responds to requests from regulatory agencies and/or distributors to resolve (potential) regulatory issues and questions to continue evaluations of product submissions.


* Monitors the progress of the regulatory authority review process through appropriate communications with the RA Consultants, Distributors and reporting out to Business Units as needed.


* Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.

 

* Maintains the product registration and documentation databases and regulatory submission files.


* Assess change request from the legal manufacturer for compliance with regulatory requirements and government submissions.


* Provide support to currently marketed products as necessary. This includes, reviewing labeling; reviewing promotional material; reviewing product changes; preparing documentation for changes requiring government approval; and preparing submissions and reports for regulatory agencies as required by product status.


* Support activities such as audits, regulatory agency inspections, etc, as needed.


* Remains current with local and international regulations in Latin American countries and communicates that information to the organization (including distributors when necessary).


* Perform other related duties as assigned.

Job Requirements

REQUIRED QUALIFICATIONS

* Bachelor’s Degree in science, biology, chemistry or a related field.

 

* A minimum of 4+ years of related job experience is required for this position.

 

* Must be fluent in English and Spanish with good verbal and written skills in both languages.

 

* Ability to travel approximately 5%, including internationally

 

PREFERRED QUALIFICATIONS

* RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

 

Must be detail-oriented, self-motivated and able to work independently in a multi‑tasking environment.

 

* Knowledge of international regulations applicable to medical device requirements in LATAM is preferred.

 

* Solid knowledge of Latin America regulatory product registration processes, including class III devices.

 

* Practical (hands-on) experience in a medical device regulatory environment preparing submissions.

 

* Experience interacting with regulatory agencies preferred.

 

* Maintain proficiency in applicable regulatory requirements.

 

* Project management experience highly preferred; experience with prioritizing multiple tasks and driving results.

 

* Brazilian Portuguese is a plus.

 

* Advanced skills in Microsoft Office programs, including Word, Excel and PowerPoint, Access and Adobe Acrobat.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

 

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

The Olympus Latin America Division (LAD) encompasses three subsidiaries within Olympus Corporation of the Americas including Olympus Latin America, Olympus America de México, and Olympus Optical do Brazil. Throughout their respective regions, each subsidiary manages Olympus’ operations, distributor partnerships, and workforces in roles such as sales, marketing and support functions. For more information, visit olympuslatinoamerica.com and truetolife.com.

Olympus…True To You. True To Society. True To LIFE.

 

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Florida (US-FL) || Miami || 


Job Segment: Scientific, QA, Quality Assurance, Project Manager, PLM, Engineering, Quality, Technology, Management

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