Specialist, Sr. Regulatory Affairs

hace 3 meses

Ciudad de México Olympus Corporation of the Americas A tiempo completo

**Workplace Flexibility**:Hybrid**

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

**Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.**

**Our Purpose is to make people’s lives healthier, safer, and more fulfilling.**

**Our Core Values are reflected in all we do**: _Integrity - Empathy - Agility - Unity - Long-Term View_

We deliver on our purpose and our core values by staying **True to Life.**

**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._Maintains the product registration and documentation RA databases. _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. _Assess change requests from the legal manufacturer for compliance with regulatory requirements and government submissions. _Provide support to currently marketed products as necessary._

**Job Requirements**:

- Education / Training*: _Bachelor’s Degree in science, biology, chemistry or a related field._RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred._
- Experience*: _A minimum of 8 - 10 years direct experience in regulatory affairs at a medical devices or pharmaceutical company. _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. _Maintain proficiency in applicable regulatory requirements. _Project management experience highly preferred; experience with prioritizing multiple tasks and driving results._

**Why join Olympus?**

**_ Here, people matter—our health, our happiness, and our lives._**
- Competitive salaries, annual bonus and 401(k)* with company match
- Comprehensive Medical, Dental, Visions coverage effective on start date
- 24/7 Employee Assistance Program
- Free virtual live and on-demand wellness classes
- Work-life balance supportive culture with hybrid and remote roles
- 12 Paid Holidays
- Educational Assistance
- Parental Leave and Adoption Assistance
- Volunteering and charitable donation match programs
- Diversity & Inclusion Programs including Colleague Affinity Networks
- On-Site Child Daycare, Café, Fitness Center**
- _US Only_
- **Limited locations_

**About us**:
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and mínimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.

**Olympus is dedicated to building a diverse, inclusive and authentic workplace**

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

**_
Let’s realize your potential, together._**

Olympus requires all US new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

Posting Notes: || Mexico (MX) || Ciudad de México (MX-CMX) || Mexico, D.F. ||

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