Regulatory Affairs Manager – Deciphex Ltd – Birmingham

Deciphex Ltd

We’re looking for a Regulatory Affairs Manager to join our growing team. We are expanding our exciting product and service range into new markets.

This role is remote and open to candidates in Ireland, UK & USA.

Role and Responsibilities:

  • Actively involved with the QA/RA Director, Commercial and R&D teams to generate regulatory plans and strategies for medical products and services
  • Develop, compile and review the technical documentation required for regulatory submissions: USA, EU, Middle East and North Africa (MENA), Gulf Cooperation Council (GCC), Rest of World (ROW) as applicable for digital pathology solutions.
  • Lead submission processes for regulatory applications for new products and services to project timelines for all markets, to the applicable regulatory bodies: US (FDA, CMS-CLIA), UK (CQC), EU, Canada, MENA, ROW
  • Lead communications and engagement with Notified Bodies, Competent Authorities, and international regulatory authorities regarding regulatory submissions, license applications, vigilance and compliance activities
  • Write and submit periodic regulatory reports to authorities as required for regulatory purposes
  • Establish, manage and monitor the global regulatory registrations database, keeping the product portfolio in compliance with global regulations
  • Keep up to date on revised and interpret new medical device/ medical services regulations and standards, develop internal and global policies & procedures to ensure continuous compliance with all regulatory requirements and to determine impact on company activities.
  • Support other members of the Quality team to incorporate regulatory requirements into the Integrated Management System (IMS): Periodic policy and procedure reviews, inputs for quality management reviews, gap analysis assessments of regulations 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 staff in the UK, USA and any additional Deciphex offices with regulatory queries, customer audits, regulatory audits and inspections as required
  • Perform internal audits as required
  • Establish an effective complaint investigation process for the completion of reportable regulatory incidents
  • Global customer complaint coordinator- Logging, tracking and trending of customer complaints with global sites
  • Support GLP licence application with the relevant competent authorities and maintenance of the GLP licence for Whole Slide Image (WSI) process as required
  • Establish and co-ordinate post market surveillance (PMS) activities as required by applicable regulatory requirements.
  • Participate in clinical evaluation activities 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% (subject to Covid travel restrictions) will be required to support regulatory/ customer audits at Deciphex offices outside of Ireland (UK, USA, MENA, GCC) as required

Education / Qualifications:

  • Degree or higher in a life science subject

Required Experience for the Role:

  • 5+ years experience in regulatory affairs in a regulated life science industry (Pharma, Medical Device, IVD etc).
  • 3+ years of supervisory or management experience
  • Direct experience successfully leading regulatory submission processes
  • Experience with MENA, GCC countries (UAE and Saudi Arabia) will be ‘a distinct advantage’
  • Experience with a recognised quality guidance or standard such as ISO 13485 and/or ISO 9001 is an advantage.
  • Experience with GLP regulations or software will be ‘a distinct advantage.’
  • Experience with delivering training is an advantage.

Desired Characteristics:

  • Organised and diligent with activities
  • Good team player and have the ability to work with various groups
  • Good time keeping skills and ability to meet timelines
  • Willing to learn and be proactive in developing skills & experience
  • Technical report writing skills

Key Benefits of Working with Deciphex:

  • Flexible working hours & location
  • Work from home schedule available
  • Free onsite parking
  • Company healthcare plan (VHI Ireland)
  • Cutting Edge technology space in Life Sciences domain
  • Multicultural, diverse work team
  • Autonomy & trust among Managers and Employees
  • Continued education and learning opportunities
  • Quarterly face to face Social Events (to be reinstated post-COVID-19)
  • Ongoing online social engagement (Recently implemented in light of COVID-19 restrictions and new WFH schedule)

About the Company:

Deciphex is a rapidly growing AI technology company, based in Dublin, Ireland providing software solutions for both non-clinical and clinical Pathology. From its inception in 2017, the company has scaled rapidly to a team of over 60 people, based in 6 countries worldwide, and is projected to hit 70+ people by late 2021. The company also has US & UK subsidiaries, with plans to expand into new markets. The company has been heavily involved in R&D with several EU and national grants to drive new product pipeline development. This has been supplemented with significant investment funding from VCs and private entities to enable the company commercial development and growth.

Our current product PATHOLYTIX Preclinical enables the Pharmaceutical and Contract Research Organisation (CRO) sectors to accelerate the process of drug development. This product delivers a scalable SAAS) platform that supports management, viewing, and AI analysis of pathology images. The company boasts several of the top 10 global pharma companies as its customers.

Our current product DIAGNEXIA Clinical leverages cloud technologies to acquire and distribute clinical cases to a network of high-quality freelance pathologists for remote review and diagnosis. It provides a SAAS platform for remote clinical consultation that supports management and viewing of pathology slides and allows augmentation of digital diagnostic workflows with targeted AI capabilities.

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 travelling community or any other classification protected by applicable law.

Reference ID: DCXROLE-560

Job Types: Full-time, Permanent

Schedule:

  • Monday to Friday

COVID-19 considerations:
Recruitment campaign will be carried out remotely via Zoom.

Application question(s):

  • Are you legally authorized to work in Ireland, UK or USA?

Education:

  • Bachelor’s (required)

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