They operate independently from MHRA and provide their time on a voluntary basis. PRASEAG also input into MHRA statements, advice, and recommendations. Main Duties Of The Job We are looking for ...
They operate independently from MHRA and provide their time on a voluntary basis. PRASEAG also input into MHRA statements, advice, and recommendations. Main Duties Of The Job We are looking for ...
Head of Regulatory
San Mateo, CA · On-site
$170K - $225K/yr
Serve as the primary point of contact with regulatory authorities (e.g., FDA, Health Canada, MHRA, TGA, EU Notified Bodies) for product approvals, QMS compliance, and ongoing reporting. * Interpret ...
Head of Regulatory
San Mateo, CA · On-site
$170K - $225K/yr
Serve as the primary point of contact with regulatory authorities (e.g., FDA, Health Canada, MHRA, TGA, EU Notified Bodies) for product approvals, QMS compliance, and ongoing reporting. * Interpret ...
MHRA, EMA, FDA); * Manage training for Medpace stakeholders with respect to inspection readiness; * Conducting inspection readiness visits at selected sites (as applicable) to assess inspection risk;
MHRA, EMA, FDA); * Manage training for Medpace stakeholders with respect to inspection readiness; * Conducting inspection readiness visits at selected sites (as applicable) to assess inspection risk;
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Malvern, PA · On-site
$32.75 - $45/hr
Ensure compliance with ICH-GCP (E6(R2)/(R3)), applicable FDA/EMA/MHRA regulations, and company SOPs governing TMF content, completeness, and timeliness throughout the trial lifecycle. * Configure and ...
TMF Lead
Malvern, PA · On-site
$32.75 - $45/hr
Ensure compliance with ICH-GCP (E6(R2)/(R3)), applicable FDA/EMA/MHRA regulations, and company SOPs governing TMF content, completeness, and timeliness throughout the trial lifecycle. * Configure and ...
Serve as the primary Inspection Lead and Host for FDA BIMO, MHRA, PMDA, EMA, and other Health Authority inspections, including PV post-marketing surveillance inspections. * Lead all inspection ...
Serve as the primary Inspection Lead and Host for FDA BIMO, MHRA, PMDA, EMA, and other Health Authority inspections, including PV post-marketing surveillance inspections. * Lead all inspection ...
MHRA, EMA, FDA); * Manage training for Medpace stakeholders with respect to inspection readiness; * Conducting inspection readiness visits at selected sites (as applicable) to assess inspection risk;
MHRA, EMA, FDA); * Manage training for Medpace stakeholders with respect to inspection readiness; * Conducting inspection readiness visits at selected sites (as applicable) to assess inspection risk;
TMF Lead
Malvern, PA · On-site
$32.75 - $45/hr
Ensure compliance with ICH-GCP (E6(R2)/(R3)), applicable FDA/EMA/MHRA regulations, and company SOPs governing TMF content, completeness, and timeliness throughout the trial lifecycle. * Configure and ...
TMF Lead
Malvern, PA · On-site
$32.75 - $45/hr
Ensure compliance with ICH-GCP (E6(R2)/(R3)), applicable FDA/EMA/MHRA regulations, and company SOPs governing TMF content, completeness, and timeliness throughout the trial lifecycle. * Configure and ...
Senior Manager, Clinical and PV Quality Assurance (Inspection Readiness and Management)
Pasadena, CA · On-site
Serve as the primary Inspection Lead and Host for FDA BIMO, MHRA, PMDA, EMA, and other Health Authority inspections, including PV post-marketing surveillance inspections. * Lead all inspection ...
Senior Manager, Clinical and PV Quality Assurance (Inspection Readiness and Management)
Pasadena, CA · On-site
Serve as the primary Inspection Lead and Host for FDA BIMO, MHRA, PMDA, EMA, and other Health Authority inspections, including PV post-marketing surveillance inspections. * Lead all inspection ...
Director, Clinical Quality Assurance
Cambridge, MA · On-site
$168K - $268K/yr
Solid understanding of global clinical regulations and guidelines (ICH, FDA, EMA, MHRA) * Experience in team leadership and development (in the GCP environment preferred) * Experience in managing ...
Director, Clinical Quality Assurance
Cambridge, MA · On-site
$168K - $268K/yr
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Director, Clinical Quality and Pharmacovigilance
$87K - $119K/yr
FDA, EMA, MHRA etc.), including sponsor pre-approval and pre-license inspections supporting marketing applications (NDA/MAA). * Prepare and support internal teams, sponsors, and/or clinical sites ...
Director, Clinical Quality and Pharmacovigilance
$87K - $119K/yr
FDA, EMA, MHRA etc.), including sponsor pre-approval and pre-license inspections supporting marketing applications (NDA/MAA). * Prepare and support internal teams, sponsors, and/or clinical sites ...
Develop and implement a comprehensive, risk-based quality compliance strategy aligned with global regulatory expectations (FDA, EMA, MHRA, ICH). * Provide executive oversight of core quality systems ...
Develop and implement a comprehensive, risk-based quality compliance strategy aligned with global regulatory expectations (FDA, EMA, MHRA, ICH). * Provide executive oversight of core quality systems ...
... FDA 21 CFR MHRA Annex 11Subject Matter Expert in GxP (GDP GLP GMP) and Data Integrity Strong issue solving and analysis skills Leadership skill Essential Skills: EIS : Teamcenter Product (PLM ...
... FDA 21 CFR MHRA Annex 11Subject Matter Expert in GxP (GDP GLP GMP) and Data Integrity Strong issue solving and analysis skills Leadership skill Essential Skills: EIS : Teamcenter Product (PLM ...
Provide guidance and oversight related to health authority (FDA, EMA, MHRA, etc.) regulations that impact the Medical Affairs organization. * May assist in development or review of Medical Affairs ...
Provide guidance and oversight related to health authority (FDA, EMA, MHRA, etc.) regulations that impact the Medical Affairs organization. * May assist in development or review of Medical Affairs ...
Agile PLM Java Technical Lead
Cambridge, VT · On-site
Familiarity with industry-standard quality assurance and control principles (e.g., 21 CFR Part 11, GAMP 5). * Knowledge of health authority regulations such as FDA, 21 CFR, and MHRA Annex 11.
Agile PLM Java Technical Lead
Cambridge, VT · On-site
Familiarity with industry-standard quality assurance and control principles (e.g., 21 CFR Part 11, GAMP 5). * Knowledge of health authority regulations such as FDA, 21 CFR, and MHRA Annex 11.
Knowledge of GxP systems, risk-based quality management principles, and GCP regulations (FDA, MHRA, EMA, etc.) and guidance documents (GCP/ICH) is required. Experience supporting global clinical ...
Quick apply
Knowledge of GxP systems, risk-based quality management principles, and GCP regulations (FDA, MHRA, EMA, etc.) and guidance documents (GCP/ICH) is required. Experience supporting global clinical ...
Calibration Coordinator
Ham Lake, MN · On-site
$34/hr
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Calibration Coordinator
Ham Lake, MN · On-site
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MHRA (UK), Health Canada, TGA (Australia), PMDA (Japan), etc. * Ensure alignment with data integrity guidance (FDA, MHRA, PIC/S). * Maintain continuous inspection readiness for global regulatory ...
The successful candidate will bring deep expertise in global quality and regulatory requirements (FDA, EMA, MHRA, PMDA, TGA, Health Canada, and other applicable health authorities) for stability and ...
The successful candidate will bring deep expertise in global quality and regulatory requirements (FDA, EMA, MHRA, PMDA, TGA, Health Canada, and other applicable health authorities) for stability and ...
Associate Director - Auditor - Computer System Validation , AI Assurance, Data Integrity
Macedonia, OH · On-site
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Associate Director - Auditor - Computer System Validation , AI Assurance, Data Integrity
Macedonia, OH · On-site
Expert knowledge of FDA, EU, and MHRA GxP regulations and supporting documents, such as those from ICH and PIC/S. * Expert knowledge of industry best practices such as GAMP5, ANSI standards (S-95, S ...
Calibration Coordinator
Ham Lake, MN · On-site
$34/hr
MHRA (UK), Health Canada, TGA (Australia), PMDA (Japan), etc. * Ensure alignment with data integrity guidance (FDA, MHRA, PIC/S). * Maintain continuous inspection readiness for global regulatory ...
Calibration Coordinator
Ham Lake, MN · On-site
$34/hr
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Senior Director, Quality
Mount Vernon, IN · On-site
Serve as the primary site contact for health authority inspections (e.g., FDA, MHRA); lead responses to inquiries, facilitate investigations, and maintain strong agency relationships. * Quality Unit ...
Senior Director, Quality
Mount Vernon, IN · On-site
Serve as the primary site contact for health authority inspections (e.g., FDA, MHRA); lead responses to inquiries, facilitate investigations, and maintain strong agency relationships. * Quality Unit ...
Mhra information
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$21.28 - $26.70
3% of jobs
$26.70 - $32.12
3% of jobs
$32.12 - $37.54
8% of jobs
$39.98 is the 25th percentile. Wages below this are outliers.
$37.54 - $42.96
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$53.80 - $59.22
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7% of jobs
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| Aspect | Mhra | Pharmacist |
|---|---|---|
| Required Credentials | Regulatory knowledge, compliance certifications | Pharmacy degree, licensing, registration |
| Work Environment | Regulatory agencies, pharmaceutical companies | Community pharmacies, hospitals, clinics |
| Employer & Industry Usage | Health authorities, pharmaceutical industry | Healthcare providers, retail pharmacies |
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IDWG's Plastic, Reconstructive and Aesthetic Surgery EAG
Remote
Other
This job post has expired 1 day ago. Applications are no longer accepted.
Job description
The Interim Devices Working Group (IDWG) is looking to appoint one lay member to the Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG). PRASEAG is formed of external experts (i.e. clinicians, scientists and lay representative/s) who provide clinical and scientific perspective on the regulation of medical devices used in Plastic Surgery, both for cosmetic and reconstructive procedures. Inclusion of patient and charity representatives helps PRASEAG and MHRA better understand the impact of the issues discussed, on patients and the public. The remit of PRASEAG includes medical devices used in both surgical and non-surgical aesthetic or cosmetic procedures.
Members of PRASEAG are not employed by MHRA. They operate independently from MHRA and provide their time on a voluntary basis. PRASEAG also input into MHRA statements, advice, and recommendations.
Main Duties Of The JobWe are looking for patients who are interested in advising and providing a patient voice or breast cancer charity perspective to inform at key points of our regulatory decision-making process for medical devices. We are looking for lay members who either have had experiences relating specifically to breast implants and/or other devices used in plastic, reconstructive and aesthetic procedures. The lay expert has an essential role in PRASEAG. Many of the issues considered are of significant public and media interest. As a result, it is essential all members make informed decisions based on the evidence presented to PRASEAG and discussed at the meetings in complete confidence. An open mind is an essential prerequisite.
The Member must be able to demonstrate the qualities, skills and experience to meet all the essential criteria for appointment.
Please note that only applications submitted to CSTRecruitment@mhra.gov.uk will be considered.
Job ResponsibilitiesFor full details on job description, please refer to advert attached in this vacancy or visit:
https://www.gov.uk/government/groups/interim-devices-working-group#current-vacancies
To make an application please email your application form, CV, completed monitoring form and declaration of interest form to: CSTRecruitment@mhra.gov.uk, quoting the position and reference PRASEAG26-2 in the subject field.
Please note that only applications submitted to CSTRecruitment@mhra.gov.uk will be considered.
Person Specification Qualifications Essential- The Member must be able to demonstrate the qualities, skills and experience to meet all the essential criteria for appointment.
- Patient that has an interest in the device areas covered by PRASEAG.
- Maintain strict confidentiality with respect to the work of the EAG.
- Be able to assimilate and interpret complex scientific information and share individual expertise or experience on specific topics or items to complement the scientific information considered.
- Be able and prepared to contribute actively to the work of the EAG. by providing a nonspecialist contribution to discussions about medical devices / research from patient and public perspectives.
- Be a skilled communicator.
- Be willing to develop a working knowledge and understanding of UK medical devices regulatory framework and procedures.
- Be willing to declare conflicts of interest.
- Be committed to the values of selflessness, integrity, objectivity, accountability, professionalism, impartiality and consistency
- Have access to digital technology such as a smartphone, tablet or laptop that will allow you to access meetings virtually on MS Teams.
- This role is not suitable for healthcare professionals or medical device industry professionals.
- Current or previous experience of committee membership(s) is important but not essential.
- Experience in undergoing, or a close relative undergoing reconstructive or cosmetic surgery with a breast implant/s and/or cosmetic treatments with dermal fillers, botulism toxin and/ skin treatments with external medical devices.
- Can commit to a 1 to 4-year term for this role.
- Have had breast implant surgery, or who have cared for a person who has had breast implant surgery.
- Be willing to actively contribute to discussions about breast implants to ensure the patient voice is heard.
- Be interested in the field of breast implants and how they are regulated in the UK.
- Works or worked for an organisation involved in breast implants or breast cancer.
Medicines and Healthcare Products Regulatory Agency
AddressMedicine & Healthcare Regulatory Agency
10 South Colonnade
London
E14 4PU
United Kingdom