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Medical Devices Regulatory Affairs jobs

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    • Support regulatory inspections, audits, and CAPA management.
    • Coordinate the preparation, review, and submission of PSURs, RMPs and ACOs in accordance with…
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    • Proven experience in Regulatory Affairs within the medical device industry.
    • This role is responsible for overseeing the creation, maintenance, and compliance of…
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    • Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities.
    • Perform review of medical/scientific literature to identify literature…
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    • Demonstrable experience in regulatory affairs, compliance or quality assurance.
    • Working knowledge of ISO 13485, IEC 62304 and Class III medical device…
    • 3+ years' regulatory affairs or compliance experience, ideally within medical device manufacturing or healthcare.
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    • Supporting preparation and submission of regulatory documentation for medical device applications.
    • Exposure to the full regulatory lifecycle of Class III…
    • Ensure compliance with applicable medical device regulations and internal quality standards.
    • Experience developing clinical or regulatory documentation.
    • How many years of experience do you have of Product Management & Marketing within the medical device industry?
    • Competitive salary with bonus scheme.
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    • 3–5 years' experience in regulatory affairs or medical device compliance.
    • Domain: Class III medical device · regulatory strategy and compliance.
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    • Proven experience in regulatory affairs or medical device compliance.
    • Domain: Class III medical device · regulatory and compliance affairs.
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    • Domain: Medical device · regulatory affairs and compliance.
    • Developing and maintaining regulatory strategy for medical device portfolios.
    • Domain: Medical device · regulatory affairs and compliance.
    • 3–5 years' experience in regulatory affairs or quality assurance within medical device manufacturing…
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    • 3–5 years' experience in regulatory affairs or quality management within medical device development.
    • Exposure to Class III medical device development from…
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    • Understanding of Class III medical device regulatory pathways and approval processes.
    • This is an opportunity to register your interest in future Regulatory…
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    • The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance…

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Job Post Details

Senior Pharmacovigilance Officer - job post

Milpharm Ltd
Uxbridge UB11 1AF
£28,000 - £35,000 a year - Permanent, Full-time

Job details

Pay

  • £28,000 - £35,000 a year

Job type

  • Permanent
  • Full-time

Location

Uxbridge UB11 1AF

Benefits

Pulled from the full job description

  • Sick pay
  • Life insurance
  • Company pension
  • Company events
  • On-site parking

Full job description

  • Support the UK RPP in maintaining an effective pharmacovigilance system in compliance with MHRA requirements.
  • Assist in ensuring continuous oversight of all PV activities performed internally and by third parties.
  • Support regulatory inspections, audits, and CAPA management.
  • Contribute to PV governance activities and safety compliance monitoring.
  • Provide oversight of Medical Information activities to ensure compliance with pharmacovigilance obligations.
  • Ensure product complaints, adverse events, special situations, and safety information received through Medical Information are appropriately identified, processed, and reported.
  • Support and perform reconciliation activities between Medical Information and other stakeholders
  • Ensure deviation, CAPA, change control, and risk management processes.
  • Drive inspection readiness activities across the PV system.
  • Deliver pharmacovigilance training to internal stakeholders
  • Coordinate the preparation, review, and submission of PSURs, RMPs and ACOs in accordance with regulatory requirements.
  • Preparation and implementation and maintenance of approved RMM programmes.
  • Coordinate the preparation, review, UK PSMF and all associated annexes.
  • Ensure the PSMF accurately reflects the current pharmacovigilance system and organisational structure.
  • Oversight and management of safety variations

Qualification:

  • Essential Degree in Life Sciences, Pharmacy, Nursing, Medicine, or related healthcare discipline.
  • Significant pharmacovigilance experience within the pharmaceutical industry.
  • Strong knowledge of UK Pharmacovigilance legislation and MHRA GVP requirements.

Job Types: Permanent, Full-time

Pay: £28,000.00-£35,000.00 per year

Benefits:

  • Company events
  • Company pension
  • Life insurance
  • On-site parking
  • Sick pay

Ability to commute/relocate:

  • Uxbridge UB11 1AF: reliably commute or plan to relocate before starting work (required)

Education:

  • Bachelor's (required)

Licence/Certification:

  • UK Work Authorisation (required)

Work Location: In person

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