Rimsys is on a mission to improve global health. Our Regulatory Information Management (RIM) software digitizes and automates regulatory activities, helping MedTech companies establish and secure global compliance and bring life-saving products to market more quickly. Rimsys is headquartered in Pittsburgh, PA (position can be in-office, hybrid or remote) and is growing rapidly with an expanding list of large enterprise customers.
We are extraordinarily proud of the company we've built so far not to mention humbled to be recognized as a Best Place to Work in Pittsburgh. Our people are Rimsys' biggest competitive advantage and we'll continue to invest in our team and people-first culture.
As a Regulatory Specialist at Rimsys, you will collaborate with internal and external stakeholders by defining and clarifying regulatory requirements/workflows and demonstrating coverage within the Rimsys solution. You will be responsible for monitoring and evaluating the dynamic global regulatory environment, interpreting these requirements, and identifying changes that impact the Rimsys solution and customers. The Regulatory Specialist will also create and deliver regulatory training to internal team members on the ever-changing and complex global regulatory landscape.
Reporting directly to the Director of Regulatory, you will dive deep into regulatory details to surface information that’s highly valuable to our customers and present it across a variety of different formats and media.
This role is available in the following locations: Pittsburgh, PA, Hybrid or Remote
Time Zone Requirements
Our team operates on the East Coast time zone.
Our team has regular on-site collaboration sessions. These occur one week per year at our Pittsburgh office. If you need to travel to attend this session, Rimsys will cover travel related expenses.
How you’ll make an impact
Provide regulatory expertise during the development, marketing, sales, implementation, and support processes. Teaming up by:
Conducting product demos and Q&A sessions for current and future customers
Leveraging existing regulatory experience to demonstrate the value in a Regulatory Information Management (RIM) platform
Providing regulatory knowledge to clarify customer regulatory requirements, workflows, and deliverables and mapping them to the Rimsys solution
Providing guidance and feedback during the development lifecycle on workflows, system requirements, and the confirmation of software features
Drafting current and emerging regulatory topics for company postings
Establish regulatory requirements for enhancements to the Rimsys solution
Monitor global regulatory information/intelligence resources (e.g., industry groups, newsfeeds, global regulatory websites, guidance, etc.) and assess for applicability/impact to customers and the Rimsys solution
Provide internal training to educate, engage and align team members on regulations impacting the MedTech industry as well as their interpretation and application to the Rimsys software
What we’re looking for:
Bachelor's degree is required
3+ years of MedTech (medical devices, IVD, software) regulatory experience
Experience working for a MedTech company
Excellent working knowledge of global MedTech regulations
Ability to function effectively in a self-directed environment and interact well with other teams (e.g., product management, development, sales, etc)
Excellent planning, written, and communication skills
We'll be extra excited if you have this experience:
Knowledge of eQMS/Enterprise ERP software tools
Experience registering devices within the EU (MDR/IVDR) and USA (510K/PMA)
Benefits available to Rimsys team members include, but are not limited to:
- Flexible working options (in our Pittsburgh office, remote or hybrid)
- Comprehensive medical, dental and vision coverage
- Training and resources for personal and career growth
- Life insurance benefits
- 401(k) plan
- Generous vacation policy (Unlimited PTO with a minimum 2 weeks OOO)
- Weekly social events
- Convenient office location with on-site parking for team members in our Pittsburgh office
Rimsys is a proud Equal Opportunity Employer. We are committed to embracing diversity and inclusion in our hiring practices and our employees' experience. We celebrate all cultures, backgrounds perspectives and experiences and know that we can only become better together.
Rimsys is a world-leading provider of Regulatory Information Management (RIM) software for medical technology companies. It consolidates all the functions of regulatory affairs, making product registration, standards management, essential principles/GSPR, regulatory submissions, post market suveillance and regulatory intelligence easy. Developed specifically for medtech and catered to your company’s workflows, Rimsys is the first and only holistic RIM software platform on the market for regulatory affairs professionals to digitize, automate, and navigate the global regulatory landscape.