Regulatory Affairs Specialist

Location

• U.S. based role working from home
• Limited international travel to Europe as required
• Regular collaboration with global teams across the U.S., Europe, and Canada

About this Role (Responsibilities):

• This is a remote role with some travel required to global offices.
• Actively involved with the Laboratory Operations team, QA/RA team, Commercial, legal and R&D teams to generate regulatory plans and strategies for digital pathology products and services including with AI technology in North America.
• Maintain and implement the compliance plans to ensure continued compliance for our services and products in North America.
• Make submissions for regulatory and accreditation applications for new products/ services to project timelines to the applicable regulatory bodies including state agencies such as US (FDA, CMS-CLIA-LDT), Canada (CAP, SCC).
• Develop, compile and review the technical documentation required for regulatory submissions: USA, Canada. Support Regulatory Affairs team with UK, EU, Rest of World (ROW) submissions as needed for digital pathology solutions and services.
• Lead communications and engagement with Notified Bodies, Competent Authorities, and international regulatory authorities regarding regulatory submissions, license & accreditation applications, vigilance and compliance activities.
• Coordinate post market surveillance (PMS) activities for products and services. Write and submit periodic regulatory reports to authorities as required for regulatory purposes.
• Establish, manage and monitor the global regulatory requirements database, keeping the product portfolio in compliance with global regulations.
• Keep up to date on changing regulatory requirements and standards including FDA/LDT rule changes, emerging AI regulations, privacy/security regulations etc. Conduct regulatory gap analyses and impact analysis. Develop internal and global policies & procedures to ensure continuous compliance with all regulatory requirements.
• Assist in maintaining the Regulatory Affairs Intranet site.
• Collect and report on compliance metrics as directed by the Regulatory Affairs Manager.
• Support other members of the Quality team to incorporate regulatory requirements into the Integrated Management System (IMS): Change management, complaint handling, training, periodic document reviews, inputs for quality management reviews and guidance to peers and cross-functional groups etc.
• Review of Change Requests for product & service changes which may impact regulatory and customer filings.
• Support employees with regulatory queries, customer audits, regulatory audits and inspections as required.
• Perform internal & supplier audits as required.
• Develop and deliver company training modules on regulatory processes.
• Complete all mandatory company training and job specific training required for the role, including Information Security Management System (ISMS), GLP, DocuSign, SDLC as applicable.
• International travel approx. 10% will be required to support regulatory/ customer audits at Deciphex offices globally as required.

About You (Skills and Experience):

• Bachelor's degree in Computer Science or Life Science industry.
• 3+ years experience in regulatory affairs in a regulated life science industry in USA. Experience with histopathology laboratory accreditation to such standards as CAP, CLIA (USA), ISO 15189:2022.
• Experience with SaMD and medical device regulations is required
• Experience with digital pathology scanning equipment and software systems is a distinct advantage.
• Experience with laboratory billing practices, Stark Law, anti kickback, anti markupF rule would be a distinct advantage.
• Experience with AI technologies and emerging standards is an advantage.

What are the benefits of working with Deciphex?

• A true sense of meaning in your work by contributing to better patient outcomes.
• The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment.
• A chance to work on exciting and challenging unique projects.
• Regular performance feedback and significant career growth opportunities.
• Competitive salary with performance based annual increments.
• A highly collaborative and supportive multi cultural team.

About the Company

Through the work that we do, the team at Deciphex helps pharma to accelerate the process of essential drug development and helps cancer patients get timely and accurate diagnosis.

Founded in Dublin in 2017, Deciphex has scaled rapidly to a team of over 190 people and counting who are providing software solutions to address the pathology gap in research pathology and clinical areas. We have offices in Dublin, Exeter & Oxford (England), Chicago and Toronto and are expanding our team throughout the world.

We are software developers, clinical specialists, artificial intelligence engineers, operations professionals and so much more, all working as one team to support our customers and patients.

We are looking for highly motivated & individuals who are excited to take on challenges and value making a difference in their day-to-day work to join our team!

Our company is seeking a Regulatory Affairs Specialist to join our team, with a focus on supporting digital pathology products and services in the healthcare markets in North America. The ideal candidate will be responsible for ensuring that our digital pathology products and services complies with regulatory requirements.

Read more about Deciphex here and more about our incredible team on our Careers Page here

Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the traveling community or any other classification protected by applicable law.

A copy of our Privacy Policy can be viewedhere