Specialist, Sr. Regulatory Affairs

**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..**Job Requirements**:**Must have**:- Bachelor’s Degree in science, biology, chemistry or a related field.- 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.- Advanced skills in Microsoft Office programs, including Word, Excel and PowerPoint, Access and Adobe Acrobat.- Ability to travel approximately 5%, including internationally- Must be fluent in English and Spanish with good verbal and written skills in both languages.**Nice to have**:- RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.- Brazilian Portuguese is a plus.**Soft Skills**:- Demonstrates ability to manage multiple activities and tasks.- Must be detail-oriented, self-motivated and able to work independently in a multi-tasking environment.- Strong time management and communication skills.- Strong organizational and follow-up skills, as well as attention to detail.- Ability to comply with constantly changing regulatory procedures and prioritize work effectively.- Ability to analyse and resolve non-routine regulatory issues using independent judgment.**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 c