Medical Device Compliance jobs in Cambridge
- GV HealthStevenage
- Act as the official company representative for product regulatory compliance, declaring and evidencing product compliance with necessary regulations to external…
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- Salary Search: Product Compliance Officer salaries in Stevenage
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View similar jobs with this employerMundipharma Research LimitedCambridge CB2 1NT- Strong governance, compliance, and risk management expertise within a global regulatory environment.
- Governance & Compliance: Establish and oversee global…
- ZEISS GroupCambridge
- Proven sales experience within the medical device, healthcare or life sciences sector.
- Experience selling capital medical equipment.
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View similar jobs with this employerHologicCambridge CB4 0WN- Company pension
- Experience in the regulated medical device industry, ideally supporting product lifecycle and regulatory compliance activities.
- SThreeCambridge
- Knowledge of relevant regulatory frameworks and standards, including ISO 13485, IEC 62304, and Class III medical device regulations.
- SThreeCambridge
- Domain: Class III medical device · regulatory compliance · product lifecycle management.
- Prior experience supporting medical device submissions or regulatory…
- EnveaCambridge
- Annual leave
- Company pension
- You will coordinate activities such as EMC compliance tests and standard-compliant design for UKCA/CE labelling.
View similar jobs with this employerBard Pharmaceuticals LimitedCambridge CB2 1NT- Previous expertise in developing packaging solutions for the pharmaceutical and medical device industries would be advantageous.
Senior/Managing Consultant: Chemical Regulatory
Often replies in 2 daysYordas GroupUnited Kingdom- Company pension
- As a senior member of the Global Notifications team, you will work closely with the Business Unit lead to provide strategy, leadership and guidance to industry…
- Evolve SelectionCambridge
- Company pension
- Private medical insurance
- ABPI qualified professional – you understand the Code of Practice and bring credibility, compliance, and confidence to every interaction.
- Evolve SelectionCambridge
- Company pension
- Private medical insurance
- ABPI qualified professional – you understand the Code of Practice and bring credibility, compliance, and confidence to every interaction.
- Owen DanielsStevenage
- Formal training or qualifications in CE/UKCA marking and regulatory compliance.
- Are you a Mechanical Engineer with experience in product development and…
- Zenopa RecruitmentUnited Kingdom
- Pay rise
- Company pension
- Ensure all work is completed to quality, compliance and customer standards.
- Their systems play a critical role in monitoring temperature-sensitive products,…
View similar jobs with this employerPA ConsultingMelbourn- Significant experience (typically 8+ years) within medical device industry.
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View similar jobs with this employerPA ConsultingMelbourn- This role focuses on advising clients on the regulatory, Quality and compliance aspects of medical devices, through a strong understanding of regulatory and…
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View similar jobs with this employerPA ConsultingMelbourn- Significant experience in medical device and/or drug-device combination product development;
- This role calls for a senior engineer with substantial experience…
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Product Compliance Officer
Job details
Full job description
Location:
Stevenage, Herts
Status:
Full-time
Salary:
£45,000 - £55,000
Working Hours:
8:30-17:00
Product Compliance Officer
Introduction
A great opportunity for a professional from a product regulatory
compliance background with scientific understanding to join a
successful technical department in a thriving international science
and technology company.
The company provides infection prevention and control solutions to
the healthcare sector, with a focus on environmental hygiene and
hazardous waste management products. Products include disinfectants,
cleaners, decontamination systems, waste bags and protective clothing.
This role offers unique opportunities for professional development
and career advancement, building a highly transferable skill set
across a diverse range of products.
The company has grown rapidly over the last 30 years, providing key
support to the NHS during the COVID-19 pandemic and releasing various
groundbreaking technologies since.
rapidly due to changes in sustainability and global supply chains,
creating the ideal space for an individual seeking an exciting new
challenge and accelerated career path.
Role Overview
The Product Compliance Officer does not have any direct reports and
does not report to a regulatory professional. Given the nature of
this role, the following abilities are essential:
Independent Working & Ownership
Ability to work independently, manage projects and critically review
your own work with minimal oversight, requiring significant attention
to detail.
Cross-Functional Engagement
Proactively engage with and maintain ongoing visibility across all
business functions relevant to product regulatory compliance, whilst
maintaining acute awareness of wider business priorities.
This involves frequent engagement with colleagues across all
departments and the ability to initiate and maintain multiple
internal communication channels, supported by good interpersonal
skills.
The Product Compliance Officer must be a visible presence within
the organisation, working amongst different teams in different
locations and managing their schedule accordingly.
Constructive Collaboration
collaboration with colleagues. Demonstrate sensitivity when
balancing regulatory expectations against the capabilities and
responsibilities of colleagues, establishing clear goals with
realistic timelines.
Primary Responsibilities
- Take full ownership of product regulatory compliance, establishing requirements, monitoring changes and ensuring adherence to applicable product regulations.
- Act as the official company representative for product regulatory compliance, declaring and evidencing product compliance with necessary regulations to external parties.
- Advise on product-related activities, including sourcing and development, covering composition, packaging, labelling and marketing.
- Conduct horizon scanning for impending changes to product regulations and create action plans accordingly.
- Assist with domestic and European product registrations.
- Set up and run safety data sheet software to support current products and new product development.
Additional Responsibilities
- Author external documents and communications.
- Establish and maintain relationships with external consultants and regulators.
- Deliver internal training.
- Maintain a detailed understanding of GV Health’s products to support compliance work.
- Develop and maintain an understanding of regulations and standards relating to all products in the company’s portfolio, including but not limited to REACH, CLP, BPR, PPE, medical devices, CE/UKCA markings, ADR, UN certifications, Kitemarking, poison centre notifications, UFI numbers and product standards (EN, ISO, ASTM and others).
- Collect, centralise and manage regulatory documentation.
- Maintain a high level of external visibility on regulations by establishing a network of contacts, regularly attending external events and setting up professional memberships.
- Maintain visibility of costs associated with consultancy, third-party testing and company accreditations or memberships to assist the department head in performing cost-benefit analysis.
- Contribute to the product non-conformance system.
additional tasks to the Product Compliance Officer that are not
captured within this job specification and which they will be
expected to carry out.
Role Details
- Department: Part of the Technical Department, reporting to the Head of the Technical Department and working closely alongside technical colleagues.
- Working hours: Monday to Friday, 8:30am–5pm.
- Location: On site at least 3 days per week, split between technical, office and warehouse premises, with flexibility to work from home up to 2 days per week.
Candidate Requirements
Essential
- Degree-level qualification in a chemical discipline.
- At least 3 years’ experience working in a regulatory compliance role.
- At least 2 years of regulatory experience with chemical products, including REACH and CLP regulations.
- Direct experience and a successful track record of creating safety data sheets for formulated chemical mixtures.
- Own a car and have a clean driving licence.
Preferred
- Regulatory experience in one or more of the following: biocidal product regulations, PPE regulations, medical device regulations or ADR.
Skills
- Excellent written and oral communication skills.
- Ability to quickly learn and implement complex subject matter, often scientific in nature.
- A high level of motivation, organisation, independence and diligence, effectively managing time and prioritising work.
- Excellent IT skills, including high proficiency with Microsoft Office programs, including Word, Outlook, Excel and PowerPoint.
- Ability to effectively record, summarise, report and present data in understandable formats for non-technical colleagues.
Attributes
- Process-oriented, attentive to detail and results-driven.
- Thrives on a variety of experiences and interaction with different teams.
- Takes a mature, constructive, objective and realistic approach to identifying and solving complex problems, conducting root cause analysis and implementing corrective measures.
- Demonstrates pragmatism in light of unexpected challenges and critical thinking under pressure, often multitasking to tight deadlines.
- Wide appreciation of operational and commercial considerations.
Benefits
- 25 days annual leave plus 8 statutory public holidays.
- Ability to buy up to 3 days or sell up to 2 days of annual leave.
- Private healthcare (including cover for pre-existing conditions).
- Company pension contribution.
- Electric car scheme via salary sacrifice.
- Flu vaccination.
- Eye test contribution.
- Access to confidential online counselling and wellbeing support.
- Additional employee benefits and reward programmes.
How to Apply
careers@gvhealth.com,
with Product Compliance Officer in the subject line.