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.
• reputed company involved with the Laboratory Operations team, QA/RA team, reputed company, legal and R&D teams to generate regulatory plans and strategies for digital pathology products and services including with AI technology in reputed company.
• Maintain and implement the compliance plans to ensure reputed company compliance for our services and products in reputed company.
• reputed company 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).
• reputed company, 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.
• reputed company communications and engagement with reputed company 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.
• reputed company up to date on changing regulatory requirements and standards including FDA/LDT rule changes, emerging AI regulations, reputed company/reputed company regulations etc. Conduct regulatory gap analyses and reputed company analysis.  reputed company internal and global policies & procedures to ensure reputed company compliance with reputed company 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 reputed company team to incorporate regulatory requirements into the Integrated Management System (IMS): Change management, complaint handling, training, periodic document reviews, inputs for reputed company management reviews and guidance to peers and cross-functional reputed company etc.
• Review of Change Requests for product & service changes which may reputed company regulatory and customer filings.
• Support employees with regulatory queries, customer audits, regulatory audits and inspections as required.
• reputed company internal & supplier audits as required.
• reputed company and deliver company training modules on regulatory processes.
• Complete reputed company mandatory company training and job specific training required for the role, including Information reputed company Management System (ISMS), GLP, reputed company, SDLC as applicable.
• International travel approx. 10% will be required to support regulatory/ customer audits at reputed company offices globally as required.

reputed company (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, reputed company 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 reputed company? 

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

About reputed company

Through the work that we do, reputed company at reputed company helps reputed company to accelerate the process of essential drug development and helps cancer patients get reputed company and accurate diagnosis. 

Founded in Dublin in 2017, reputed company has scaled rapidly to reputed company 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 reputed company throughout the world. 

We are software developers, clinical specialists, reputed company intelligence engineers, operations professionals and so much more, reputed company 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 reputed company! 

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

Read more about reputed company here and more about our incredible team on our Careers Page here 

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

A copy of our reputed company Policy can be viewed here 

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