Regulatory Affairs Specialist

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    "datePosted": "2026-05-19",
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    "description": "<p><span style=\"color: rgb(34, 34, 34); font-size: 10pt; font-weight: bold\">Location</span></p>\n<ul>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">U.S. based role working from home</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Limited international travel to Europe as required</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Regular collaboration with global teams across the U.S., Europe, and Canada</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"color: rgb(34, 34, 34); font-size: 10pt; font-weight: bold\">About this Role (Responsibilities): </span></p>\n<ul>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">This is a remote role with some travel required to global offices.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Actively involved with the Laboratory Operations team, QA/RA team, Commercial, legal and R&amp;D teams to generate regulatory plans and strategies for digital pathology products and services including with AI technology in North America.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Maintain and implement the compliance plans to ensure continued compliance for our services and products in North America.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">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).</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">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.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Lead communications and engagement with Notified Bodies, Competent Authorities, and international regulatory authorities regarding regulatory submissions, license &amp; accreditation  applications, vigilance and compliance activities.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Coordinate post market surveillance (PMS) activities for products and services. Write and submit periodic regulatory reports to authorities as required for regulatory purposes.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Establish, manage and monitor the global regulatory requirements database, keeping the product portfolio in compliance with global regulations.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">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 &amp; procedures to ensure continuous compliance with all regulatory requirements.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Assist in maintaining the Regulatory Affairs Intranet site.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Collect and report on compliance metrics as directed by the Regulatory Affairs Manager.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">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.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Review of Change Requests for product &amp; service changes which may impact regulatory and customer filings.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Support employees with regulatory queries, customer audits, regulatory audits and inspections as required.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Perform internal &amp; supplier audits as required.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Develop and deliver company training modules on regulatory processes.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Complete all mandatory company training and job specific training required for the role, including Information Security Management System (ISMS), GLP, DocuSign, SDLC as applicable.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">International travel approx. 10% will be required to support regulatory/ customer audits at Deciphex offices globally as required.</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"color: rgb(34, 34, 34); font-size: 10pt; font-weight: bold\">About You (Skills and Experience):</span></p>\n<ul>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Bachelor's degree in Computer Science or Life Science industry. </span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">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.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Experience with SaMD and medical device regulations is required</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Experience with digital pathology scanning equipment and software systems is a distinct advantage.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Experience with laboratory billing practices, Stark Law, anti kickback, anti markupF rule would be a distinct advantage.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Experience with AI technologies and emerging standards is an advantage.</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"color: rgb(34, 34, 34); font-size: 10pt; font-weight: bold\">What are the benefits of working with Deciphex? </span></p>\n<ul>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">A true sense of meaning in your work by contributing to better patient outcomes. </span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">A chance to work on exciting and challenging unique projects. </span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Regular performance feedback and significant career growth opportunities.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Competitive salary with performance based annual increments.</span></li>\n<li><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">A highly collaborative and supportive multi cultural team. </span></li>\n</ul>\n<p><br></p>\n<p><span style=\"color: rgb(34, 34, 34); font-size: 10pt; font-weight: bold\">About the Company</span></p>\n<p><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">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. </span></p>\n<p><br></p>\n<p><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">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 &amp; Oxford (England), Chicago and Toronto and are expanding our team throughout the world. </span></p>\n<p><br></p>\n<p><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">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. </span></p>\n<p><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">We are looking for highly motivated &amp; individuals who are excited to take on challenges and value making a difference in their day-to-day work to join our team! </span></p>\n<p><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">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. </span></p>\n<p><br></p>\n<p><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">Read more about Deciphex </span><a href=\"https://www.deciphex.com/\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-size: 10pt\">here</span></a><span style=\"color: rgb(34, 34, 34); font-size: 10pt\"> and more about our incredible team on our Careers Page </span><a href=\"https://www.deciphex.com/careers#join\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-size: 10pt\">here </span></a></p>\n<p><br></p>\n<p><span style=\"color: rgb(34, 34, 34); font-size: 10pt\">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.</span><br></p>\n<p><br></p>\n<p><span style=\"color: rgb(34, 34, 34); font-size: 10pt\"><span style=\"font-size: 10pt\">A copy of our Privacy Policy can be viewed<span> </span></span><a href=\"https://url.avanan.click/v2/r02/___https://www.deciphex.com/legal/privacy-policy___.YXAxZTpkZWNpcGhleDphOmc6YWRlMDMyNzk3NWJmNzBmNDFjODVhYmUyNDUyZWIwNjk6NzowYzliOmUxMmQ0NzRiMGI0NmMzYjgzYWRiNmJmMTYzZTYxZDE0Y2VjNzU3MzVkZTA1YTA0ZmI0NjllN2JhODM0ODcxN2Y6aDpUOk4\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-size: 10pt\">here</span></a><span style=\"font-size: 10pt\"> </span></span></p>",
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