Head of Regulatory Affairs

2 weeks ago

London, United Kingdom Machine Medicine Full time

Machine Medicine Technologies is facilitating the next generation of neurotherapeutics by building software for the intelligent, personalised optimisation of neuromodulation and other precision therapeutics. Our flagship product, Kelvin, is in use at multiple deep brain stimulation (DBS) sites across the globe, enabling the collection of large datasets of unparalleled quality. This data is being utilised to develop a SaMD (Software as Medical Device) tool for automated clinical assessment of Parkinson’s disease.
The FDA awarded our technology Breakthrough Device Designation, recognizing its potential to revolutionize the MedTech industry.
Based in central London (Bermondsey), our company is growing rapidly with 30+ full-time employees and over £6.We have published papers in numerous high-quality, peer-reviewed journals, including Sensors, Intelligence-Based Medicine, and Nature Parkinson’s Disease.
25 days annual leave (+ Bank Holidays)
~ Unlimited coffee & tea at the office
~ Private Medical coverage with Vitality Health
~ Cycle to work scheme
~ Electric car scheme

The Quality team at our company plays a pivotal role in ensuring the excellence of our products and services. The team guarantees that our medical device functions with pinpoint accuracy, high reliability, and utmost safety. they provide the assurance needed to not only meet but consistently exceed the expectations of regulatory bodies, healthcare professionals, patients, and clients.
And support the design and development of new SaMD for other movement disorders, under the Kelvin series

Reporting directly to the CEO, the Head of Quality and Regulatory Affairs will play a vital role as a member of the leadership team, and leading a team of three.
If you are a self-starter with an entrepreneurial spirit, passion for the field and perseverance towards a goal, you will fit right in. This is a superb opportunity for an ambitious Quality professional, with relevant previous experience, to take personal ownership and deliver outstanding results.
Quality and Regulatory
Maintain the highest degree of product quality and quality systems, grounded by the ability and vision to anticipate and prevent quality and/or regulatory problems.

Ensure compliance with ISO 13485 Quality Management System and maintain ISO 27001 certification.

Ensure all external audits with Notified Bodies, Regulatory Authorities, and Customers are managed to ensure a positive outcome.

Ensure compliance with local and international regulatory compliance in line with relevant legislation

Report vigilance issues and information security incidents to regulatory authorities in terms

Leadership and Planning:
Grow, motivate and empower the Quality team, through performance reviews and development.

Define quality strategy and implement procedures. Strong inclination towards and appetite for technology and creative thinking. Knowledge and experience in medical device quality systems and regulatory processes including ISO 13485, ISO 14971, ISO 27001, 21 CFR Part 11, 21 CFR Part 820, MDR 2017/745, IEC 62304.

Experience with Software as a Medical Device (SaMD)

Proven track record in interactions with Notified Bodies/Regulatory Authorities, especially the FDA

Quality certification:

  • Sds Author

    4 weeks ago

    London, United Kingdom VRS Regulatory Full time

    We are looking for a Safety Data Sheet / SDS Author / Regulatory Officer for a London based consumer products company. Your role will be varied and include researching pending changes developments to global chemical regulations, developing regulatory documents (SDSs, labels etc) for new and existing products, and providing regulatory support to internal...

  • Head of Regulatory Affairs

    4 weeks ago

    London, United Kingdom Pharma Search Full time

    Do you have the desire to help lead a dynamic and growing business? Our client is a highly dynamic, entrepreneurial and innovative business, a commercial stage molecular diagnostics company developing ground-breaking diagnostic solutions. Their products and services are designed to improve clinical practice for the benefit of patients, clinicians, payers and...

  • Head of Renewables Regulatory Affairs Europe

    4 weeks ago

    London, United Kingdom RWE Offshore Wind Full time

    **Head of Renewables Regulatory Affairs Europe & APAC (d/f/m)**: - **Location(s)**: - London, City of London, GB, EC2R 8HP - Copenhagen, 84, DK, 1620 - Hamburg, HH, DE, 20354 - Essen, NW, DE, 45141 **RWE Offshore Wind GmbH** **To start as soon as possible, **full time **, **permanent** RWE is looking to fill a position as Head of Renewables Regulatory...

  • CMC Regulatory Affairs Director

    4 weeks ago

    London, United Kingdom Walker Cole International Ltd Full time

    Walker Cole International are looking for a CMC Regulatory Affairs Director to join an established Pharmaceutical Business in the UK. In this role you will be responsible for the development and execution of CMC regulatory strategy for the business. As the CMC Regulatory Affairs Director, you will be responsible for: * The development and creation of the...

  • Regulatory Affairs AVP

    1 week ago

    City of London, Greater London, United Kingdom Michael Page (UK) Full time

    About Our Client Our client is a highly regarded international bank based in their City of London office. Job Description Liaising with the regulator to manage regulatory risk, and implementing new regulations in order to maintain a strong relationship with the regulator and avoid fines. This role holder will be one of the approved contacts with the...

  • Senior Vice President, Head of Global Regulatory Affairs

    4 days ago

    London, United Kingdom Beacon Therapeutics (USA) Inc Full time

    Are you a seasoned Senior Regulatory Leader looking for a new and exciting challenge? Beacon Therapeutics (USA) Inc is seeking a talented individual to join us as a Full Time Senior Vice President, Head of Global Regulatory Affairs, completely remote! In this role, you will have the opportunity to lead our global regulatory strategy and drive submissions for...

  • Regulatory Affairs Manager

    3 weeks ago

    London, United Kingdom Walker Cole International Ltd Full time

    Walker Cole International is searching for a Regulatory Affairs Manager to join a global pharmaceutical company. As the Regulatory Affairs Manager you will be responsible for EU regulatory activities including lifecycle management, submissions to EU regulatory bodies, preparing for new MAAs and developing regulatory strategy (throughout product...

  • Regulatory Affairs Manager

    4 weeks ago

    London, United Kingdom Walker Cole International Ltd Full time

    Walker Cole International is searching for a Regulatory Affairs Manager to join a global pharmaceutical company. As the Regulatory Affairs Manager you will be responsible for EU regulatory activities including lifecycle management, submissions to EU regulatory bodies, preparing for new MAAs and developing regulatory strategy (throughout product lifecycle). ...

  • Head of Public Affairs

    3 days ago

    London, United Kingdom Information Commissioner's Office Full time

    **Details**: **Reference number**: - 295019**Salary**: - £63,223 - £72,337- £63,223 - £72,337 pa, with potential for further progression to £81,448 pa with our pay progression scheme- A Civil Service Pension with an average employer contribution of 27%**Job grade**: - Other- Equivalent grade: Grade 6**Contract type**: - Permanent**Business...

  • Regulatory Affairs Consultant

    4 weeks ago

    London, United Kingdom Brightwork Ltd Full time

    BaxMed – Ad-Hoc Senior Regulatory Affairs Consultant Led by Stuart Baxter, a seasoned professional with a distinguished career in Regulatory Affairs, BaxMed Regulatory Ltd is an exciting early-stage organisation formed to provide Regulatory and Quality Compliance Services for the global Medical Device / healthcare sector. With a core ethos and commitment...

  • Regulatory Affairs Consultant

    4 weeks ago

    London, United Kingdom Brightwork Ltd Full time

    BaxMed – Ad-Hoc Senior Regulatory Affairs Consultant Led by Stuart Baxter, a seasoned professional with a distinguished career in Regulatory Affairs, BaxMed Regulatory Ltd is an exciting early-stage organisation formed to provide Regulatory and Quality Compliance Services for the global Medical Device / healthcare sector. With a core ethos and commitment...

  • Head of Quality and Regulatory Affairs

    4 weeks ago

    London, United Kingdom Pharma Search Full time

    Do you have the ability to lead and inspire others? Do you have the drive, enthusiasm and talent to develop others? Do you have the experience to design and implement a global strategy? Do you have the desire to help lead a dynamic and growing business? Our client is a highly dynamic, entrepreneurial and innovative business, a commercial stage molecular...

  • Regulatory affairs senior

    2 weeks ago

    London, United Kingdom Compliance Professionals Full time

    Our client is a successful banking firm with a strong global presence, offering a comprehensive range of services across corporate and investment banking activities. Act as a subject matter expert in Regulatory Affairs. Maintain an effective, professional and proactive relationship with UK regulators and assist the Local Compliance Officers in dealing...

  • Regulatory Affairs Manager

    1 week ago

    London, United Kingdom Allen Recruitment Consulting Full time

    Are you an experienced Regulatory Affairs professional with a background in Chemistry, Manufacturing and Controls and experience working in the Biopharmaceutical/Biotechnology industry, and are you looking for a new opportunity? We have your next role, we are recruiting for a Regulatory Affairs CMC Manager with Post Approval Submissions and who has...

  • Regulatory Affairs Team AVP

    2 weeks ago

    London, United Kingdom Compliance Professionals Full time

    THE COMPANY: Our client is a successful banking firm with a strong global presence, offering a comprehensive range of services across corporate and investment banking activities. THE RESPONSIBILITIES: Act as a subject matter expert in Regulatory Affairs. Maintain an effective, professional and proactive relationship with UK regulators and assist...

  • Regulatory Affairs Officer

    1 week ago

    London, United Kingdom Black Swan Group Full time

    Exciting Opportunity for Regulatory Affairs AVP: Are you a regulatory compliance expert seeking your next career move? My client are a Global banking organisation on the lookout for a talented individual to join our team as a Regulatory Affairs Assistant Vice President (AVP). Key Responsibilities: Develop and maintain relationships with UK regulators,...

  • Regulatory Affairs Officer

    1 week ago

    London, United Kingdom Black Swan Group Full time

    Exciting Opportunity for Regulatory Affairs AVP: Are you a regulatory compliance expert seeking your next career move? My client are a Global banking organisation on the lookout for a talented individual to join our team as a Regulatory Affairs Assistant Vice President (AVP). Key Responsibilities: Develop and maintain relationships with UK regulators,...

  • Regulatory Affairs Specialist

    5 days ago

    London, United Kingdom Meet Full time

    I am seeking a highly motivated and experienced Regulatory Affairs Specialist with expertise within OTC/Cosmetics experience to join us on a contracted basis for a period of 6 to 12 months. As a key member of the Regulatory Affairs team, you will play a crucial role in ensuring our products comply with all relevant regulations and standards in various...

  • Regulatory Affairs Specialist

    4 days ago

    London, United Kingdom Meet Full time

    I am seeking a highly motivated and experienced Regulatory Affairs Specialist with expertise within OTC/Cosmetics experience to join us on a contracted basis for a period of 6 to 12 months. As a key member of the Regulatory Affairs team, you will play a crucial role in ensuring our products comply with all relevant regulations and standards in various...

  • Regulatory Affairs Manager

    2 weeks ago

    Uxbridge, Greater London, United Kingdom Park Street People Full time

    An innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...