Senior Regulatory Affairs Specialist

Clinical & Regulatory · Philadelphia, Pennsylvania
Department Clinical & Regulatory
Employment Type Full-Time
Minimum Experience Senior Manager/Supervisor

About Proscia

Pathology is at the center of medicine, and is undergoing a profound transformation as the final frontier of digitization in healthcare. We started Proscia to accelerate pathology’s transition from microscope to images, and to use that data to change the way we think about cancer. We can’t change medicine alone. That’s why we’re looking for curious thinkers. Big dreamers. Developers, evangelists, pathologists, and scientists. Exceptional talent to help us use great power for good and advance humankind.

 

At Proscia, we push the limits of medicine and technology, solving problems the world has never solved before. We build software used by thousands of scientists and pathologists, who work on the front lines of fighting big enemies, like cancer, for patients around the globe. To accelerate our vision, Proscia has raised $72MM in funding from great investors like Highline Capital Management, Triangle Peak Partners, Alpha Intelligence Capital, Scale Venture Partners, Hitachi Ventures, Flybridge, and more.

 

About this Position

The Regulatory Affairs Specialist will be responsible for providing the pre & post-market regulatory support to the business with the primary responsibility for a specific region (e.g. - EU & Canada), and backup support to the other region(s) and Quality Assurance as needed. 

 

Responsibilities: What You’ll Do


  • Collaborate with the Product/Technology Teams to develop regulatory strategies, obtain and maintain product approval, and serve as a communication liaison on regulatory issues
  • Communicate and interface directly with RA authorities to ensure product approvals are achieved in a timely manner
  • Communicate Country/region-specific regulatory requirements to the Regulatory/Quality team leaders and assist with the regulatory strategies
  • Plan, prepare and submit regulatory submissions for new products, product changes, and re-registrations as required for the specific countries/regions
  • Track and coordinate regulatory submission activities to ensure timeliness and commitments are met 
  • Collaborate with the Clinical Affairs team on projects requiring the collection of clinical data for supporting regions
  • Review and approve test protocols to support regulatory submissions  
  • Provide support to currently marketed products as necessary including input on change requests, etc.
  • Review device labeling and advertising material for compliance with submissions and market requirements
  • Collaborate with Quality Assurance to maintain complaint handling and field corrective actions, if/when required (Depending on the experience of the RA Associate, s/he could possibly take over the compliance/recall duties) 


What we’re seeking:


Proscia is a high-growth company, and we look for the entrepreneurial thinkers that thrive in a challenging environment, that are ready to build the plane while flying it. In order to be successful in this role, you will have:


  • A Bachelor’s degree (in a life sciences, engineering, or related discipline, preferred)
  • 6+ years of experience in Regulatory Affairs in the medical device/in vitro diagnostic device industry including an in-depth knowledge and understanding of the regulatory environment
  • Regulatory submission experience to US and EU MDR/IVDR Regulations, including but not limited to 510(k), PMA, DeNovo, Technical Files, STED
  • Knowledge of submissions to other markets
  • Medical device software (S@MD) submissions and validation experience highly desirable
  • Understanding both MDSAP regulations and ISO 13485: 2016 quality system management
  • Regulatory compliance experience in the medical device/IVD area preferred
  • Hands-on experience assessing US and OUS reports pertaining to customer complaints for medical devices
  • Capacity to communicate regulations to technical functions and other organizations within the company
  • Experience managing relationships with FDA and international customers (e.g., regulatory agencies, distributors, etc.)
  • Ability to execute regulatory strategies that align with business deliverables
  • Exceptional communication skills, both written and verbal
  • Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making
  • Excellent writing skills with ability to write detailed information for submissions


Beyond Just Work

As a company in the healthcare field, we want our people to be happy and healthy, in and out of the office. In addition to competitive pay, we ensure everyone on our team is supported with savings, schedule, and insurance options that promote long-term health and personal growth.

 

Our office environment is designed for creativity and agility: with walls as notepads and couches for collaboration. We’re located in the heart of Philadelphia, with views of the city atop the train station so you can spend your time focusing on what matters most. Yes, we have the free food, gourmet coffee, craft beer, massage chairs, and wellness rooms —but you’ll come for the challenge, the camaraderie, and the opportunity to do bold work.

 

At Proscia, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Proscia is proud to be an equal opportunity workplace.

Thank You

Your application was submitted successfully.

  • Location
    Philadelphia, Pennsylvania
  • Department
    Clinical & Regulatory
  • Employment Type
    Full-Time
  • Minimum Experience
    Senior Manager/Supervisor