Poole Bay Holdings Ltd

Compliance Manager

Poole Bay Holdings Ltd

full-time

Posted on:

Location Type: Hybrid

Location: Poole • United Kingdom

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Salary

💰 £50,000 per year

About the role

  • Develop and deliver the PBH Group Product Compliance strategy in alignment with the overall Group Strategy.
  • Identify all applicable regulatory and legal requirements across Pharmaceutical, Medical Devices and other related product categories.
  • Construct and implement structured compliance plans to ensure ongoing regulatory adherence.
  • Establish governance, policies and compliance controls across product lifecycles.
  • Provide regular compliance reporting to the Operations Director and Board.
  • Monitor regulatory changes and ensure timely implementation of required updates.
  • Act as the company’s nominated Responsible Person (RP) registered with the MHRA.
  • Ensure full compliance with GDP (Good Distribution Practice) requirements.
  • Maintain and oversee the Wholesale Distribution Authorisation (WDA).
  • Ensure appropriate GDP training, documentation and audit readiness across the business.
  • Lead MHRA inspections and manage responses to regulatory findings.
  • Maintain RP oversight of storage, transportation, supplier qualification and distribution controls.
  • Ensure compliance of Medical Device products (including Koolpak, gloves and related ranges) with UK and EU MDR and ISO 13485 standards.
  • Collaborate with our external Medical Device consultants to maintain regulatory compliance.
  • Oversee technical documentation, declarations of conformity and product registrations.
  • Ensure post-market surveillance, vigilance and reporting obligations are met.
  • Own and maintain the Group Quality Management System (QMS).
  • Ensure compliance with ISO standards including ISO 9001 and other relevant certifications.
  • Plan and manage internal audits and external certification audits.
  • Implement corrective and preventive actions within agreed timeframes.
  • Drive continuous improvement across quality and compliance processes.

Requirements

  • Completed GDP training course suitable for RP eligibility. [Desirable]
  • Eligible to act as Responsible Person (RP) under MHRA requirements. [Essential]
  • ISO 9001 Lead Auditor or Internal Auditor qualification. [Essential]
  • Strong understanding of GDP and Wholesale Pharmaceutical regulations. [Desirable]
  • Ability to construct and implement structured compliance frameworks. [Essential]
  • Excellent analytical and risk assessment capability. [Essential]
  • Confident communicator able to engage with regulators and senior stakeholders. [Essential]
  • Detail-oriented with strong governance mindset. [Desirable]
  • Proactive and commercially aware approach to compliance. [Desirable]
  • Proven experience in Wholesale Pharmaceutical distribution environment. [Desirable]
  • Experience acting as RP or Deputy RP (or demonstrably eligible to act as RP). [Desirable]
  • Experience managing MHRA inspections and regulatory audits. [Desirable]
  • Experience in Medical Device compliance environment. [Desirable]
  • Demonstrable track record of implementing and maintaining ISO certifications. [Essential]
Benefits
  • Hybrid working (3 days in office minimum)
  • Performance based bonus scheme
  • 25 days holiday per annum (including Christmas closure) rising to 26 days after 5 years and 27 days after 10 years, plus bank holidays (pro-rated for part-time staff)
  • £200 per annum for health and wellbeing activity / gym membership (after 1 year of service)
  • Voucher awards for ideas
  • Social committee organising departmental events and activities
  • Summer BBQ and/or Christmas party for whole company and partners
  • Free parking
  • Modern offices with kitchen and break facilities
  • Community / Charity day with line manager approval
  • Opportunity to get involved with events and initiatives to support local charities
  • 1 piece of PBH branded merchandise as a welcome / thank you for being part of the PBH team!
  • 10% discount at a local independent gym
  • Ongoing support, development and training in line with needs of the role and business.
  • Financial support to cover cost of specialist eyesight tests for DSE users & glasses for DSE use (including frames that cost up to £50)
  • Auto-enrolment for eligible staff - 8% Pension with NowPensions – (3% Employer & 5% Employee on qualifying earnings)
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
compliance strategy developmentregulatory adherencecompliance reportingGDP (Good Distribution Practice)Wholesale Distribution Authorisation (WDA)ISO 13485QMS (Quality Management System)internal auditsregulatory auditspost-market surveillance
Soft Skills
analytical capabilityrisk assessmentcommunicationgovernance mindsetproactive approachcommercial awarenessdetail-orientedstakeholder engagementleadershipcontinuous improvement
Certifications
GDP training courseResponsible Person (RP) eligibilityISO 9001 Lead AuditorInternal Auditor qualification