The Quality and Regulatory Assistant will support the Quality and Regulatory Officer in maintaining an accurate and effective Integrated Management System (IMS) in accordance with medical standards. The role will also support with Post Market Surveillance activities for Osteotec’s own products.

Reporting to: Operations Manager Nordics

Hours per Week: 37.5

Location: Head Office, Newbury, UK

Responsibilities:

• IMS document completion and online record storage in accordance with ISO13485, ISO 9001 and ISO 14001
• Assisting with the non-conformance process
• Performing the approval process for new and amended standard operating procedures
• Liaising with potential suppliers, customers and distributors, obtaining relevant approval information and auditing where necessary
• Supporting managers with training records
• Monitoring manufacturing process and ensuring safety of the devices. Goods inward quality inspection
• Assisting with Osteotec devices technical files and ensuring records are updated accordingly
• Data collection from QMS and analysis, to aid continuous improvement
• Collaborate with UK sales team and overseas partners to gain post-market feedback
• Gather information and review PMS report periodically
• Assisting with internal audit organisation and reporting

Essential:

• A Degree in any relevant scientific discipline
• A high level of attention to detail and ability to follow procedures accurately
• Excellent written and verbal communication skills
• Highly organised and able to work alone when required
• Proficient with Microsoft Office (Excel, Word, PowerPoint, Outlook)
• Maths and English Language A level, preferably grade B or above (Desirable)
• Previous experience in quality management or regulatory affairs in medical devices, pharmaceutical or food industry
• An ambition to develop a career in a QARA function in the medical device industry

Highly Desirable:

• Experience in regulatory affairs or in quality management systems relating to medical devices.

This job description is not exhaustive but outlines the main requirements.

To serve customers by providing product and service information and processing orders through to despatch and delivery to customer.

Reporting to: Operations Manager Nordics

Hours per Week: 37.5

Location: Malmö, Sweden

Daily duties:

• Communications with customers and sales representative/sales agents.
• Answer telephone
• Liaise with customers for booking of Loan and Consignment Sets and other orders
• Processing of orders and loans for products using DEAR CRM.
• Tracking of any Back Orders: Pricing Queries: Quotations.
• Answer product and service questions; suggesting information about other products and services.
• Open customer accounts by recording account information.
• Maintain customer records by updating account information.
• Prepare Invoices after despatch of orders.
• File completed Customer Orders and records.
• Assist with resolving of product or service problems by clarifying any customer’s complaint; determining the cause of the problem; selecting and explaining the best solution to solve the problem; expediting correction or adjustment; following up to ensure resolution.
• Maintain financial accounts by processing customer adjustments.
• Prepare product or service reports by collecting and analysing customer information.
• Contribute to team effort by accomplishing related results as needed.
• Assist with preparing orders within Warehouse environment ready for despatch to customers.
• Ensure that all aspects of Quality Management System and QAPs are followed and contribute to continuous improvement plans via CAPA system
• Learn other job roles within the company in order to assist during holiday and sickness period.
• Any other relevant, reasonable ad hoc duties that may be requested.

Essential:

• Medical Device Industry – Experience within the industry dealing with sterile and non-sterile implantable medical devices.
• Ability to communicate in a highly effective manner and work both independently and as part of a team on assignments. Must be IT literate and efficient in an administrative environment. They must have the ability to work on their own initiative, prioritising and organising workload. Problem solving skills and a great telephone manner are also vital to this role.
• Demonstration of evidence of the following:
  • Involvement in the continuous improvement of the departments processes, focusing on Quality, productivity and Customer Engagement
  • Active involvement in team engagement
• Meticulous attention to detail and accuracy in work
• Computer literacy – able to utilise a range of Microsoft Office applications and other appropriate company systems when required (including MS Word, Outlook, Excel)
• High level of written and verbal communication skills
• Proactive approach and ability to work independently and as part of a small but dynamic team
• Highly organised and able to prioritise own workload
• Excellent secretarial and administrative skills
• High standard of spelling and grammar
• Flexibility – must be able to deal with different levels of workload
• Good team player

Highly Desirable:

• Office Environment experience working in a professional office environment.
• Proven excellent communication skills
• A levels or higher (or equivalent)

Equipment / software packages used:

• Microsoft Word, Microsoft Excel, Microsoft Outlook, Powerpoint, DEAR, Power BI

Competencies:

• Decision making/judgement – selects effective approaches to solving issues, based on available information and business objectives and escalates appropriately
• Relationship builder – builds and maintains relationships within the team and across the wider organisation
• Excellent communication skills
• Proactive – has a pro-active and independent personality, ability to manage their own workload and prioritise appropriately
• Strong internal drive and motivation to make a difference and add value to an organisation

This job description is not exhaustive but outlines the main requirements.

The ideal candidate will be responsible for assisting in the supply, tracking, delivery of loan kits & provide necessary on-site support for implantation procedures to our customer base from a case cover perspective.

You will be part of the team working within the wider operations team providing a key interface with the customer, supporting all aspects of the kits operations and customer care process (supporting our field sales people, preparing kits for dispatch to hospitals, liaising with Customer Service department on missing implants, returns of kits, updating records etc.).

There will be a requirement to be on-site to support implantation procedures, collection of all usage data and provide necessary site support.  This will require a candidate that can maintain professional and credible image with key theatre stakeholders, consultants, clinical nurse teams etc, liaising with all these relevant stakeholders and Field sales team to ensure safe and successful device implantations.

Working in a team environment, the successful candidate will demonstrate excellent external and internal customer focus throughout. You will work in a dynamic environment and each day presents different challenges. You will work with a supportive and collaborative team where you will have the opportunity to become a true product expert and can develop a strong partnership with our customers and sales team.

This is an important role within the organisation supporting the sales team and ensuring their success. You will have a direct impact on patient outcomes through your high standards in service quality, professionalism and passion to help others.

Reporting to: Sales Manager

Hours per Week: 37.5

Location: Malmö / Lund

Daily duties:

• Provide customers with technical advice and appropriate training on the safe and effective use of the company’s products and surgical techniques, primarily in a theatre setting
• Engage with both existing and new surgeons to develop robust sales opportunity pipeline and advise appropriate sales leads
• Support customers and sales team with activities relating to the management of the company’s stock and equipment including consignment inventory, loan kits
• Maintain up-to-date records of customer activity on the company’s ERP system, including information on customer usage, purchasing protocols and relevant competitor activity, working in tandem and providing relevant support with the appropriate Sales Lead
• In addition to the customer facing activity, the Clinical Support/ Loan kits Co-ordinator will also support the development of product & procedure knowledge with the sales team. This may be teaching in a theatre setting, classroom teaching, or involvement in our induction training programme

Responsibilities:

• Receiving and dispatch of loan sets for surgery
• Processing and handling customer enquiries from internal and external customers
• Management of international shipments from the US or Europe
• Ensuring accurate usage recording from cases
• Inventory control and stock review as necessary
• Partner with Filed sales team to ensure a seamless service is provided to our customers

Desired Profile:

To be considered for this role you will be passionate about excellent customer service and a real desire to be part of a team that has a direct influence to improve the quality of life of patients and their clinical outcomes.  Ideally you will be familiar with working in a quality driven environment with a strong commitment to deliver positive results for our customers.

Specifically, we are seeking:

• Someone who is familiar working in a quality & compliance driven environment
• A commitment to work with products that require careful handling and respect
• A real passion for delivering great customer service and going above and beyond the role
• A high attention to detail with a strong orientation for processes
• Ability to work under pressure to tight deadlines
• Sound organisational and time management skills
• Good task prioritisation
• Strong problem-solving skills and the desire to ‘own and resolve’ issues
• Excellent verbal communication skills, with the ability to build rapport with people at all levels
• A positive and resilient nature
• Any experience in inventory control would be advantageous

This job description is not exhaustive but outlines the main requirements.

The Territory Sales Manager is responsible for achieving sales in the designated territory in line with company objectives.

With the guidance of the Sales Manager, the Territory Sales Manager is responsible for all elements of the sales cycle. This includes setting objectives, sales planning, implementing sales activities, reviewing results and amending the plan.

The Territory Sales Manager will grow Osteotec’s business by directly selling products to customers that include Orthopaedic Surgeons, clinical and non-clinical decision makers, and optimising customer service and supporting the acquisition of new customers through technical expertise in the designated territory.

Reporting to: National Sales Manager or Business Development Manager

Hours per Week: 37.5

Location: Field based

Responsibilities:

• To take full responsibility for promoting, demonstrating and selling a range of orthopaedic products into the NHS and private hospitals
• To achieve sales results in line with the monthly and annual sales target and KPI metrics
• To sell and demonstrate medical equipment within the theatre and clinical environment
• Conduct trials and evaluations of product in theatre and clinical environment to drive sales
• Ensure safe and effective use of the company’s technology
• Provide outstanding customer service to existing customers and during all activities related to the acquisition of new customers
• Independently construct and implement an effective sales business plan
• Management of all resources and materials in their related sales area, including the effective management of consignment stock in all hospitals
• Maintain and build relationships with key customers and decision makers including orthopaedic surgeons, surgical theatre staff, hospital administration & procurement with the goal of achieving the commercial objectives of the organisation, whilst at all times promoting the positive image of the company to the customer
• Organising and conducting training workshops with participation from surgical & theatre staff
• Regular reporting to Sales Managers, on the sales and the market
• Additional responsibilities as directed by managers
• Builds and maintains relationships with key opinion leaders in the designated territory
• Conducts business activities in compliance with ethics and legal requirements
• Liaise with other company functions to ensure achievement of sales objectives
• 80% of your time in theatre environment
• Commitment to ongoing personal and professional development by keeping up to date with company products, competitors, and latest developments in the industry
• Any other relevant, reasonable ad hoc duties that may be requested.

Essential:

• Effective negotiator
• Excellent interpersonal skills
• Decisive, assertive with a winning personality
• Ambitious and driven to achieve results
• Tenacity, self motivation and a ‘can do’ attitude
• Ability to prioritise, multi-task and adapt to changes
• Ability to effectively plan, and execute to a defined sales strategy
• Disciplined, organised, with a sense of responsibility
• Ability to work under pressure
• Flexibility, mobility
• A business minded personality
• Ability to handle criticism and conflict and actively seeks continuous improvement.
• Computer skills, including Microsoft Office Suite and Microsoft Outlook
• Proven sales, account management and business development experience
• Track record of consistently achieving sales and targets within set budget expenses
• Medical device sales experience essential, ideally in orthopaedics or the operating theatre environment
• Driving license as this is a field based role

Highly Desirable:

• Bachelors degree, life science or business discipline preferred

Equipment / software packages used:

• Microsoft Word, Microsoft Excel, Microsoft Outlook, Powerpoint, Power BI

Competencies:

• Decision making/judgement – selects effective approaches to solving issues, based on available information and business objectives and escalates appropriately
• Build and maintain relationships within the team and across the wider organisation
• Excellent communication skills
• Proactive – has a pro-active and independent personality, ability to manage their own workload and prioritise appropriately
• Strong internal drive and motivation to make a difference and add value to an organisation

This Job description is not exhaustive but outlines the main requirements.

The role will be responsible for providing training support to Orthopaedic Surgeons, Theatre Staff, Procurement Departments and Hospital Management within the HSE and private sector.

Reports to: National Sales Manager or Business Development Manager

Hours per Week: 37.5

Location: Field based

Responsibilities:

• Collaborate effectively with sales teams through on-site product demonstration and remote presentation as required
• Provide and continuously improve product education and training programmes for existing as well as new customers, arranging training with regularity
• Provide support in the operating theatre for existing and potential customers
• Develop actionable market knowledge pertaining to the orthopaedic space enabling greater levels of product adoption in key sites
• Monitor competitor data and opportunities
• Ensure presence at relevant congresses/exhibitions to further promote education around the product value proposition
• Conduct regularly consignment stock checks.
• Provide administrative support to sales team members within the region
• Any other relevant, reasonable ad hoc duties that may be requested

Essential:

• Must have Clinical experience in a related product/therapy area (I.e. ODP)
• Previous experience working within the theatre environment and knowledge of orthopaedics
• Strong knowledge and understanding of human anatomy and physiology
• Strong verbal and written communication skills
• Track record of interfacing with varying stakeholders internally, and externally with customers and 3rd party partners.
• Experience working independently and collaborating cross-functionally whenever is beneficial
• Willing to travel extensively and fulfil role functions autonomously.
• Full, driving licence.

Desirable:

• Previous ODP / ODA or Theatre Nursing experience is desirable
• Commercial experience within the orthopaedic/spine space would be ideal

Equipment / software packages used:

• Microsoft Word, Microsoft Excel, Microsoft Outlook, Powerpoint, Power BI

Competencies:

• Decision Making/Judgement – Selects effective approaches to solving issues, based on available information and business objectives and escalates appropriately
• Build and maintain relationships within the team and across the wider organisation
• Excellent communication skills
• Has a pro-active and independent personality, ability to manage their own workload and prioritise appropriately
• Strong internal drive and motivation to make a difference and add value to an organisation

This Job description is not exhaustive but outlines the main requirements.