Current jobs related to Head of Quality and Regulatory - Bristol, Bristol - OKKO Health

  • Head of Quality and Regulatory

    7 hours ago

    Bristol, Bristol, United Kingdom OKKO Health Full time £70,000 - £80,000

    Job Title: Head of Quality and RegulatoryLocation: Bristol, with a minimum of 1 day a week in the officeSalary: £70,000-£80,000 Full-Time EquivalentEmployment type: Permanent, with part-time working consideredAbout Us:OKKO Health is at the forefront of developing innovative medical software solutions, improving patient care through cutting-edge...

  • Regulatory Analyst

    2 weeks ago

    Bristol, Bristol, United Kingdom Pax2Pay Ltd Full time £40,000 - £80,000 per year

    Job Title: Regulatory Analyst (CASS)Location: Bristol MissionPax2pay is a rapidly growing FinTech business on a mission to modernise and simplify payments for the Travel industry. Our customers are some of the biggest players in the Travel sector and our partners are key players in the FinTech world. Established in 2019, we are currently a growing team of...

  • Regulatory Analyst

    1 week ago

    Bristol, Bristol, United Kingdom Pax2Pay Ltd Full time £40,000 - £60,000 per year

    Job Title: Regulatory Analyst (CASS)Location: BristolMissionPax2pay is a rapidly growing FinTech business on a mission to modernise and simplify payments for the Travel industry. Our customers are some of the biggest players in the Travel sector and our partners are key players in the FinTech world. Established in 2019, we are currently a growing team of 28,...

  • Regulatory Financial Modelling Lead

    1 week ago

    Bristol, Bristol, United Kingdom South West Water Full time £55,000 - £70,000 per year

    AtSouth West Waterwe believe that the strongest businesses are built on solid, stable foundations - with a vision and a culture that gives them the freedom to change, improve and innovate.We're proud to be responsible for providing reliable, efficient and high-quality drinking water and wastewater services for the beautiful South West area.And we have huge...

  • Advanced Quality Engineer

    2 weeks ago

    Bristol, Bristol, United Kingdom Crux Product Design Full time £60,000 - £100,000 per year

    Position OverviewAre you passionate about shaping the future of medical device quality? Join a team of expert engineers and human factors specialists driving innovation for the world's leading pharmaceutical and device companies.We're hiring in our Bristol office for a senior-level role that blends technical expertise with a drive to ensure that quality...

  • Head of Airspace Services

    1 week ago

    Bristol, Bristol, United Kingdom Sagentia Aviation Full time £60,000 - £100,000 per year

    Department:Airport and AirspaceLocation:BristolDescriptionSagentia Aviation are proven aviation experts who deliver full lifecycle support across complex airspace, ATM and aerodrome system projects.We provide the skills and capacity to support and manage regulation, safeguarding and certification within airspace, technical safety and CNS systems.We have an...

  • Senior Litigation and Regulatory Lawyer

    2 days ago

    Bristol, Bristol, United Kingdom Office for Students Full time

    Senior Litigation and Regulatory LawyerBristol or London£68,720 - £72,004 + £7,500 allowance plus London weighting £3,566 (where appropriate)Generous Civil Service defined benefit pensionUse your litigation expertise in an organisation that's shaping policy and regulationThe opportunity Make a real difference to the lives of students by bringing your...

  • Head Chef

    6 days ago

    Bristol, Bristol, United Kingdom The Hen and Chicken Full time £35,000 - £38,500 per year

    Aprox 43 hours a week. 5 days Wednesday - Sunday inc. Fixed days off Monday & Tuesday+10% of salary monthly stock bonus on achieving 70% gross profitThe Hen & Chicken has a long established food trade, predominantly a grill style menu mixed with stone baked pizzas, using local suppliers & fresh ingredients; most dishes are made from scratch on the premises...

  • Quality Systems Engineer

    15 hours ago

    Bristol, Bristol, United Kingdom Vertical Aerospace Full time

    Our missionAt Vertical Aerospace, we are pioneering the way for electric aviation. The VX4, our eVTOL (electric, vertical, take-off and landing), 'zero emissions' aircraft will set a new safety standard for how we will navigate the sky.We won't realise our mission following the same legacy processes and traditions our predecessors followed, instead, we want...

  • Head of Digital Engagement

    2 weeks ago

    Bristol, Bristol, United Kingdom University of the West of England Full time £45,000 - £65,000 per year

    Job Description The University's Strategic Communications and Marketing department is responsible for raising the profile of UWE Bristol locally, regionally, nationally and internationally. It delivers strategic communications, brand, marketing, alumni engagement and philanthropy for one of the UK's largest and most progressive universities.The Head of...

Head of Quality and Regulatory

2 weeks ago

Bristol, Bristol, United Kingdom OKKO Health Full time £70,000 - £80,000 per year

Job Title: Head of Quality and Regulatory

Job Reference:

Location: Bristol, with a minimum of 1 day a week in the office

Sal
ary
: £70,000-£80,000 Full-Time Equivalent

Employment type: Permanent, with part-time working considered

About Us:

OKKO Health is at the forefront of developing innovative medical software solutions, improving patient care through cutting-edge technology. As a dedicated Software as a Medical Device (SaMD) company, we are committed to maintaining the highest standards of quality and compliance in all aspects of our operations. We are looking for a motivated Head of Quality and Regulatory to join our team.

Job Description:

The Head of Quality and Regulatory is a key member of the management team, reporting directly to the CEO. This role is responsible for providing strategic and technical leadership for Quality and Regulatory compliance across all aspects of the business. Working cross-functionally, you will be a key contact for external regulatory authorities as well as having ownership of the QMS.

You will have a strategic, pragmatic quality mindset, be proactive with a resolution driven attitude and will possess a strong knowledge of medical device quality systems. You will be passionate about putting patient safety first and playing your part in creating a more effective, compliant and efficient business.

Key Responsibilities:

  • Lead and manage Quality and Regulatory teams to ensure all business, regulatory, compliance and team development requirements are met.
  • Act as appointed Management Representative.
  • Communicate the importance of meeting customer, statutory and regulatory requirements to staff.
  • Directly responsible for the implementation, maintenance and continuous improvement of all aspects of the company Quality Management System.
  • Establish and maintain Quality Objectives. Report on Key Performance Indicators (KPIs) in order to ensure adherence to process and prevent occurrence of any non-conformity relating to products, processes or systems.
  • Ensure product designs comply with Design Controls and are validated, ensuring compliance with regulatory requirements and follow change control. Ensure quality input in Design Reviews. Ensure quality representation at business gate reviews.
  • Ensure detection of product and quality management system nonconformities and addressed through the use of the quality policy, quality objectives, audit results, post-market surveillance, analysis of data, corrective actions, preventive actions and management review.
  • Maintain company regulatory registrations.
  • Escalate issues directly to the CEO if necessary.
  • Providing expert quality guidance across the business coaching and mentoring with business units to ensure quality is embedded across all related activities.
  • Manage the Quality function within budget, including resource planning for budgetary requirements and staffing resources on projects and QMS activities, driving continuous improvement and high levels of service.
  • Support with information security management system training.

Qualifications:

  • Qualified to degree level (science or engineering advantageous).
  • Extensive experience (10 years+) in a medical device regulated manufacturing environment with specific knowledge of requirements of GMP, ISO 13485, ISO 14971, MDR & IVDR (2017/745 & 746); US FDA CFR Part 820, Medical Device Single Audit Programme (MDSAP), IEC 62304, ISO 80002 and associated regulations.
  • Proven experience in a similar quality leadership role, including experience dealing with Certification bodies, Notified bodies or competent authorities.
  • Experience in understanding, interpreting, and advising on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of devices to expedite submission, review and approval of global applications.
  • Proven experience in providing leadership, direction, and focus to company site quality to ensure operational excellence, structured growth, and long-term strategic management.
  • Demonstrate a working understanding of regulatory, risk management (ISO14971), new technologies/trends, and design control related fields.
  • Proven ability to work effectively and efficiently both within regulated environments and hybrid agile R&D environments, with the ability to adapt priorities to the business requirements effectively.
  • Strong interpersonal, collaboration and negotiation skills, as well as leading and mentoring teams.
  • Strategic thinker with the ability to influence at an executive level and develop positive stakeholder relationships.
  • A confident leader who will drive simplification of processes, striving for a lean and nimble organisation.
  • Desirable to have experience using electronic quality management systems.
  • Desirable to have experience in writing and reviewing commercial quality agreements.
  • Desirable to have experience in product development.
  • Desirable to have experience in information security / GDPR / HIPAA.

We Offer:

  • Competitive salary and benefits package (including Vitality Health Insurance).
  • Opportunity to contribute to a dynamic and innovative healthcare team.
  • Professional growth and development opportunities.
  • Flexible working hours and remote work options.