Our Core purpose:
Strolll exists to give people a new reality; that inspires them to believe in limitless human potential to overcome their most difficult rehabilitation challenges.
Our Mission:
Strolll is transforming the world of rehabilitation and physiotherapy with its state-of-the-art software, strolll® for Augmented Reality (AR) glasses; with a focus on individuals living with Parkinson's disease and other neurological disorders, .
Our Shared Objective:
To build the most used rehabilitation software in the world.
The role:
As the Senior Regulatory Affairs Specialist, you will be expected to provide regulatory support and direction for products throughout the product lifecycle working closely with engineering and sales.
You will act as the Regulatory Affairs representative within Strolll, providing insights and guidance on regulatory matters. Your role is critical in ensuring that our organization's regulatory practices are aligned with regulatory requirements, industry standards, customer requirements and best practices.
You will act as the critical liaison between Strolll, and the regulatory authorities.
You will be expected to be the internal voice advocating patient safety, efficacy and risk reduction.
Experience in medical devices is essential, software as a medical device experience is desired.
Full time remote role, with occasional travel to our Stafford office (ST16 2LP) or internationally.
Key Responsibilities
Registration Activity: Prepares, compiles, maintains and submits regulatory documents for the registration of current and new products in designated markets.
Communication: Communicate with external stakeholders e.g. notified bodies, competent authorities, or economic operators for vigilance, field actions, significant changes, technical file reviews and queries arising.
Compilation of Technical Documentation: Author or support employees to create and maintain technical document dossiers to submit to regulatory authorities.
Collaborate closely with the product manager, and project manager as well as clinical, engineering, operations, science, and quality to provide expert advice to meet, and respond to customer and regulatory requirements. Be a key stakeholder in the change management process. Answering technical and regulatory enquiries from customers and/or colleagues to support their business activities and meet requirements.
Compliance: Work within the ISO 13485 quality management system.
Product Labelling: Review and approve product labelling and marketing material for claims. Advise on regulatory compliance.
Research: Identify pathways and strategies to regulatory approval/clearance for new markets or products.
Continuous Learning: Stay updated on new and emerging applicable regulatory standards, guidelines, regulations and directives.
Post-Market Surveillance: Carry out periodic post-market surveillance to monitor and communicate changes to competitive landscape, regulations, standards, guidance, best practice, and risk. Analyse data and provide feedback to the organisation regarding trends, risks and to identify changes to products and processes.
Continuous Improvement: Assist in the actioning, monitoring and reviewing of nonconformities, customer complaints, CAPA reports, assisting with the identification and implementation of corrective / preventative actions to continuously improve products and processes.
Qualifications & Skills:
Technical Skills:
Several years of experience in regulatory compliance in the medical device sector. Knowledge of software as a medical device highly desirable.
Strong understanding of ISO 13485 quality management system and medical device regulations.
Strong knowledge of market access processes, regulations, technical file creation and maintenance for UK, USA, and Europe.
Computer literate in Microsoft office and electronic quality management software.
Good understanding of design control, and supporting processes such as software lifecycle, risk management processes, usability engineering, clinical evaluation.
Soft Skills:
Excellent communication, leadership, and negotiation skills.
Strong project management and organisational skills.
Ability to work autonomously setting tasks and direction under limited supervision.
Pro-active and demonstrates initiative, self-motivated.
Attention to detail.
Education:
Bachelor’s degree in science, engineering or equivalent experience.
Job Type: Full-time
Pay: £50,000.00-£55,000.00 per year
Benefits:

• Additional leave
• Casual dress
• Company events
• Company pension
• Flexitime
• Sick pay
• Work from home

Schedule:

• Monday to Friday

Education:

• Bachelor's (required)

Experience:

• Regulatory affairs in medical devices: 3 years (required)

Language:

• English (required)

Work authorisation:

• United Kingdom (required)

Work Location: Remote