Product Compliance Officer

GV Health Ltd; Stevenage; Híbrido; GBP 45 000 - 55 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

company pension scheme

private medical insurance

life cover

Resumo da oferta

GV Health Ltd in the United Kingdom is seeking a Product Regulatory Compliance Officer to join its technical department. You will own product regulatory compliance and act as the company representative to regulators and external partners.

You will monitor regulations across REACH, CLP, PPE, Medical Devices, CE/UKCA, and ADR, and manage SDS systems, registrations, and regulatory documentation. The role is on-site 3 days a week with some home working, and offers a clear career path.

Qualificações

• At least 3 years working in a regulatory compliance role.
• At least 2 years regulatory experience with chemical products (REACH and CLP).
• Direct experience creating safety data sheets for formulated chemical mixtures.
• Own a car and hold a clean driving licence.

Responsabilidades

• Taking full ownership of product regulatory compliance, establishing, monitoring and adhering to product regulations.
• Official company representative for product regulatory compliance, declaring and evidencing product compliance with necessary regulations to external parties.
• Advising on product related activities including sourcing and development such as composition, packaging, labelling and marketing.
• Horizon scanning for impending changes to product regulations and creating action plans accordingly.
• Assisting with domestic and European product registrations.
• Setting up and running safety data sheet software to support current products and new product development.
• Authoring external documents and communications.
• Establishing and maintaining relationships with external consultants and regulators.
• Internal training.
• Maintaining a detailed understanding of GV Health’s products to aid compliance work.
• Developing and maintaining understanding on regulations 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, kite marking, poison centre notifications, UFI numbers and product standards (ENs, ISOs, ASTMs etc.)
• Collection, centralisation, and management of regulatory documentation.
• Maintaining 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/memberships to assist the department head perform cost benefit analysis.
• Contributing to the product non-conformance system.

Conhecimentos

Attention to detail

Independent work

Interpersonal skills

Communication skills

MS Office proficiency

Ferramentas

MS Office

Descrição da oferta de emprego

A great opportunity for 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 to build a highly transferable skill set across a diverse range of products. The company has quickly grown over the last 30 years, providing key support to the NHS during the COVID-19 pandemic and released various groundbreaking technologies since. The regulatory landscape in the healthcare sector is quickly evolving 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.

Overview of the role:

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 viewed as essential:

i. Ability to work independently, manage projects and critically review own work with minimal oversight, requiring significant attention to detail.

ii. 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 requires frequent engagement with colleagues across all departments, requiring the ability to initiate and maintain multiple internal communication channels, dependant on good interpersonal skills. This requires the product compliance officer to be a ‘visual presence’ within the organisation by working amongst different teams in different locations and managing their schedule accordingly.

iii. Taking an informed, considered and constructive approach towards collaboration with colleagues. Demonstrate sensitivity when balancing regulatory expectations against the capabilities and responsibilities of colleagues, establishing clear goals with realistic timelines.

Primary responsibilities:

• Taking full ownership of product regulatory compliance, establishing, monitoring and adhering to product regulations.
• Official company representative for product regulatory compliance, declaring and evidencing product compliance with necessary regulations to external parties.
• Advising on product related activities including sourcing and development such as composition, packaging, labelling and marketing.
• Horizon scanning for impending changes to product regulations and creating action plans accordingly.
• Assisting with domestic and European product registrations.
• Setting up and running safety data sheet software to support current products and new product development.

Additional responsibilities:

• Authoring external documents and communications.
• Establishing and maintaining relationships with external consultants and regulators.
• Internal training.
• Maintaining a detailed understanding of GV Health’s products to aid compliance work.
• Developing and maintaining understanding on regulations 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, kite marking, poison centre notifications, UFI numbers and product standards (ENs, ISOs, ASTMs etc.)
• Collection, centralisation, and management of regulatory documentation.
• Maintaining 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/memberships to assist the department head perform cost benefit analysis.
• Contributing to the product non-conformance system.

The head of the technical department may also periodically delegate addition tasks to the regulatory compliance manager which are not captured within this job specification, which they are expected to carry out.

• Part of the technical department, reporting to the head of the technical department, working closely alongside technical colleagues.
• Working Monday to Friday between 8:30am – 5pm.
• Located on site at least 3 days/week, split between technical, office and warehouse premises with flexibility to work from home up to 2 days/week
• Salary on offer in the range of £45,000 - £55,000 (dependent on qualifications and experience.
• Minimum 6-month probationary period.
• Benefits include company pension scheme, private medical insurance and life cover (after successful completion of probationary period).

Candidate requirements:

• At least 3 years working in a regulatory compliance role.
• At least 2 years of regulatory experience with chemical products, including REACH and CLP regulations.
• Direct experience and successful track record creating safety data sheets for formulated chemical mixtures.
• Own a car and have a clean driving licence.

Preferred:

Regulatory experience of biocides (biocidal product regulations) and/or PPE regulations and/or medical device regulations and/or ADR

Skills:

• Excellent written and oral communication skills.
• Ability to quickly learn and implement complex subject matter, often scientific in nature.
• Demonstrate a high level of motivation, organisation, independence and diligence, effectively managing time and prioritising work.
• Excellent IT skills, including high proficiency with MS 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 orientated with an attention to detail and results driven.
• Thrives on variety of experiences, interacting with different teams.
• Takes a mature, constructive, objective and realistic approach towards identifying and solving complex problems, 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.