With accelerating growth and increasing levels of activity, Blackford is looking for a QA & Regulatory Compliance (QARC) Manager to join our Edinburgh based team. This is a unique opportunity to take a critical role which is central to our business. Strong foundations are already in place, though there is plenty of space to develop and extend our quality and regulatory agenda and contribute materially to the broader company.

The Role

With accelerating growth and increasing levels of activity, the company is now looking for a QA & Regulatory Compliance (QARC) Manager. This is a unique opportunity to take a critical role which is central to our business. Strong foundations are already in place, though there is plenty of space to develop and extend our quality and regulatory agenda and contribute materially to the broader company.

We are an ISO9001/ISO13485 manufacturer of regulatory-cleared medical device software, with all that that entails from a QA and regulatory perspective. But we are also a “reseller” of a growing portfolio of 3rd party clinical applications with a need to ensure we represent and support those products in line with their regulatory clearance. As we also integrate these applications onto our Platform we need to ensure, with our partners, that these integrations do not cross any regulatory boundaries, and are of appropriate quality in general.

The field we operate in, and our needs, are constantly changing:

  • Our portfolio currently contains around 35 third party clinical applications and could double in size over the next 2 years.
  • Although focused on US today, our partnerships are taking us into international markets so we care about regulatory regimes across the globe.
  • AI-based imaging software itself is at a very early stage and its regulation will continue to evolve as new products arrive and the various regulatory bodies catch-up with the rapid progress of this tech

All of this means there is both a ‘traditional’ quality and regulatory role to fulfil for Blackford’s own products, but also the challenge of creating a scalable way to manage the challenges around the increasing number of 3rd party applications and markets we want to address.

With this context, the successful candidate will benefit from a varied and challenging role, and involvement in several of our most strategic initiatives. You will have exposure across multiple functions internally and own a number of external relationships, including channel partners, application providers, and public bodies. The role reports directly to the CFO/COO, Scott Rutherford, who is one of three executive directors of the business.

As the job title suggests, the role extends across quality and regulatory compliance aspects of the business, both being key to the field in which the company operates. We aspire to high standards of quality, which our customers also expect and require of us. We have long held ISO 13485 and ISO 9001 certification and are currently pursuing ISO 27001 as well. From a regulatory compliance perspective, we work in an industry in which our products and services affect the way in which patients are diagnosed and treated. We therefore maintain stringent control over both our own and our partners’ products from their initial assessment, and careful marketing to their oversight in day-to-day customer use.

 

The QA & Regulatory Compliance (QARC) Manager will work closely with our existing QA Manager, Marion Peat, who has supported Blackford on a part-time basis for several years. Marion will be able to provide direction and guidance to help the candidate establish themselves in the role.

To be fully clear, quality and regulation aren’t administrative functions at Blackford – they are core to what we do and you will be directly involved in critical business activities as a result.

 

Key responsibilities will include:

 

Support senior Blackford team

  • Advise company on medical device regulatory matters; support senior team with regulatory strategy development.
  • Advise company on ISO certification matters.
  • Prepare written rationale on regulatory matters for internal & external audience.
  • Support senior team with QARC aspects of contract reviews, completion of approved supplier questionnaires, etc.
  • Project planning for major initiatives.
  • Other related activities, as assigned by the senior team.

Oversee product portfolio regulatory compliance

  • Coordinate supplier evaluation & performance monitoring.
  • Monitor ongoing compliance with external commitments (medical device regulations, ISO standards & partner/customer-specifics).
  • Maintain regulatory coverage status of product portfolio.
  • Maintain relationships with regulatory counterparts.
  • Incident management – Lead response to any incidents (re-calls, data breach, etc), including investigation, oversight of remedial actions, documentation and reporting.
  • Liaison with external organisations:
    – Interaction with sales channel and customer QARC teams, inc. external audits.
    – Liaison with regulatory authorities & certification bodies, inc external audits.
    – Manage medical device regulatory submissions (such as 510(k)) & liaison with local reps.
    – Liaison with regulatory authorities in event of recall, adverse incident, etc.

Championing the quality agenda

  • Ensure ongoing compliance to ISO 9001, ISO 13485 and other external standards as required
  • Work with in-house subject matters to develop, maintain and improve an appropriate and effective management system
  • Collation of Technical Files (Design History Files, etc.)
  • Support team with hazard management
  • Support team with project retrospectives
  • Internal audit scheduling & execution
  • Schedule and conduct management system & regulatory induction / training
  • Document control
  • Information Security support:
    – Sit on Information Security Committee; issue ISC minutes
    – Project-manage ISO 27001 certification project
    – Support Blackford team with ISO 27001 project activities

Required knowledge / experience

  • Multiple years’ experience in working in comparable roles, ideally in a medical device or software-based environment.
  • Familiarity with relevant regulations:
    – FDA 510(k); 21 CFR part 820
    – CE-marking
    – Medical Device Directive (MDD)
    – Medical Device Regulation (MDR)
  • Experience of implementing and developing a quality management system, including its rollout across a company or division.
  • Familiarity with relevant standards and guides, including:
    – BS EN ISO 13485 Medical Device QMS Requirements
    – BS EN ISO 62304 Medical Devices Software Lifecycle Processes
    – BS EN ISO 14971 Application of Risk Management to Medical Devices
    – BS EN ISO/IEC 27001 Information Security Management Systems; cybersecurity
    – BS EN ISO 9001 Quality Management System Requirements
  • Experience of managing relationships with comparable external stakeholders:
    – Quality and regulatory (incl audit) from commercial partners (suppliers, channel partners, etc)
    – Certification auditors
    – Regulatory bodies
    – Customers
  • Experience of operating across multiple functions in a high growth, fast-paced environment.

About You

Blackford are keen to hire people that share their vision and excitement about the development of their business and who want to play an important role in helping them achieve its full potential.

Candidates must bring energy, self-motivation and have a pro-active and flexible approach. You will enjoy working cross-functionally – engaging stakeholders from across the business internally and externally, demonstrating strong commercial acumen and an ability to innovate.

The successful candidate stands to gain diverse and interesting experiences through the continuing expansion of the business, working closely with the leadership team and with a real opportunity for personal development.

Personal skills

The role will suit an individual who likes a variety of work tasks, embraces change, enjoys supporting and enjoys the challenges of balancing external stakeholder and business needs.

To be successful in the role, the individual will need to demonstrate that they have exceptional organisational skills and are a highly effective communicator with a real focus on attention to detail as well as provide a proactive approach to their workload.

Key attributes will include:

  • Willingness and confidence in championing quality and compliance standards.
  • Excellent communication skills, both verbal and written – accuracy and attention to detail are key.
  • Ability to work both on your own and as part of a team.
  • Excellent planning and organisational skills having the ability to prioritise and escalate tasks as appropriate.
  • Clearly demonstrate the ability to take ownership of and complete tasks independently.
  • Ability to meet deadlines and maintain high standards even when under pressure.
  • Comfortable with working flexible hours and occasional travel when required.

Apply

 

Useful Links

The following links will provide useful background on the company:

Company website

Company eBook – Adopting a Platform Strategy

Article – The benefits of the platform business model