Walk With Path (WWP) is an award winning startup with a mission to improve mobility and reduce the risk of falls for elderly and people with chronic disease. WWP’s products are primarily medical wearables with therapeutic impact on the users. We are looking to expand into incorporating software solutions into our product offering. We are looking for an Operations and Regulatory Officer to join our team, to help with a wide variety of product development, regulatory and customer facing tasks.

Due to the nature of being in a startup, we are looking for a highly motivated candidate with broad skills and interests, who are able to juggle several tasks simultaneously.

The Operations and Regulatory Officer will work alongside the Founder, the Clinical Lead and the Lead Engineer in the company to bring a new product to market. The successful candidate will become a key member of the team, and will be expected to be able to work independently to a high standard.

Key duties of the job include:

• Studying scientific and legal documents
• Setting up a new Quality Management System (QMS)
• Gathering, evaluating, organising, managing and collating information in a variety of formats
• Ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Food and Drug Administration (FDA)
• Maintaining familiarity with company product ranges
• Planning, undertaking and overseeing product trials and regulatory inspections
• Keeping up to date with changes in regulatory legislation and guidelines
• Analysing complicated information, including trial data
• Offering advice about company policies, practices and systems
• Obtaining marketing permission
• Outlining requirements for labelling, storage and packaging
• Using a variety of specialist computer applications
• Liaising and negotiating with regulatory authorities
• Providing advice about regulations to manufacturers/scientists
• Writing comprehensible, user-friendly, clear product information leaflets and labels
• Ensuring that quality standards are met and submissions meet strict deadlines
• Preparing documentation as required

Key skills required:

• Degree in a relevant subject, such as biotechnology, public health or engineering
• Experience with setting up and maintaining QMS systems - ESSENTIAL
• Experience with ISO 13485 - ESSENTIAL
• Experience with obtaining CE marking for medical device - ESSENTIAL
• Experience with obtaining FDA/MDEL approval for medical devices - DESIRED
• IT skills
• Negotiation skills
• Analytical skills
• Time management skills
• Problem-solving skills
• Communication skills
• Organisational and project management skills
• An understanding and appreciation of relevant legal, scientific and manufacturing areas is also necessary

Benefits:

• Opportunity to join a growing start-up
• Opportunity to learn a wide variety of skills and experience daily life in a health tech startup
• Opportunity to advance quickly as the company grows

Please submit your application cover letter and CV through the Hub. Video also encouraged.

For any questions, please feel free to call Lise Pape on +44 (0) 7976842669. For more information about WWP see www.walkwithpath.com.