Specialist II, Regulatory Affairs - Neuromodulation

Additional Locations: Costa Rica-Heredia

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Hybrid Roles:

Boston Scientific's hybrid workplace includes Working From Home and onsite. You will have the opportunity to discuss details in the interview. 

About the role

The Regulatory Affairs Specialist II will support activities to drive alignment and consistency across the Neuromoduation RA Organization, throughout the product lifecycle. Working closely with functional leadership, this position will focus on continuous improvement of Neuromodulation RA data, processes, systems, and documents, and support projects to drive standardization and automation. 

Your responsibilities include:

• Support RA systems, processes, and business process to improve the overall effectiveness of the Neuromodulation Regulatory Affairs function 
• Maintain regulatory systems to ensure data integrity, resolving data inconsistencies and producing various reports as needed 
• Support efforts to improve collaboration, experience sharing, and best practices within the department and division  
• Maintain regulated data for Neuromodulation using IT systems such as SharePoint, Microsoft Teams, Regis, Windchill, etc. 
• Support regulatory information requests in support of audits, customs, post-market surveillance, government authorities, etc. 
• Provide focused regional support and triage/monitor global registration requests 
• Assist in the creation, maintenance, and tracking of submissions (i.e. 510(k), CE marking applications/change notices, technical documentation, requests for additional information, etc.) 
• Act as a core team member on global project teams, providing Regulatory Affairs feedback and guidance 
• Assist in monitoring and analyzing the impact of emerging or revised laws, regulations, enforcement actions and other changes that impact the manner by which products are regulated around the world 
• Support and maintain Quality initiatives in accordance with BSC Quality Policy 
• Continuously assess ways to improve Quality  

Required Qualifications:

• Bachelor’s degree, preferably in a scientific or technical discipline. 

• A minimum 2 years Regulatory Affairs or related experience, medical device industry experience preferred. 

• Working knowledge of FDA and EU regulations for medical devices. 

• General understanding of product development process and design control.  
• English Level desired: 90%

Preferred qualifications: 

• Ability to manage several projects 

• High attention to detail, task oriented, deadline conscientious 

• Proficiency in Excel with ability to convert data for more effective analysis 

• Advanced knowledge of Microsoft applications, including creating templates and editing/formatting complex documents in Word, PowerPoint, Visio, & Excel 

• Effective research, analytical, and problem-solving skills 

• Effective written and oral communication, technical writing, and editing skills 

• Ability to work independently within defined parameters

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures 

• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy 

• Establishes and promotes a work environment that supports the Quality Policy and Quality System 

Requisition ID: 620934

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.