Regulatory Affairs Apprentice - Liverpool, United Kingdom - Inter Scientific

Description

Job Overview:

The Regulatory Affairs Apprentice will work on and support medical device projects, with support from the Regulatory and Legal Affairs Specialist, on topics ranging from gap analysis, auditing technical files, authoring technical documentation (risk management, packaging and labelling) keeping up to date with State-of-the-Art criteria and having meetings with clients.

About us:

Inter Scientific offer innovative solutions to ensure that our client's products are compliant with regulations, directives and standards.

We work with both businesses big and small and operate on a global scale, with offices in the UK, USA, EU and Middle-East.

Our mission is to make regulatory compliance as straightforward as possible, allowing our clients to unlock global markets.

With our combined analytical and regulatory services, we offer a single point solution for product compliance and deliver the best service by collaborating with our clients to put them at the centre of our expertise and knowledge.

We strive to exceed our client needs and expectations in everything we do, which is why client satisfaction at the core of our business.

In order to achieve this, operate an Integrated Managment (IMS) based on the internationally recognised standards; ISO 9001, ISO 14001, ISO 27001, ISO 17025 and Good Manufacturing Practice (GMP).

Our values:

Quality

Embodied in every aspect of our work. Our systems are certified by the British Standards Institute (BSI) and the MHRA to international standards for Quality Management.

Our commitment to quality comes from the top of the organisation and is prevalent in every aspect of our work.

Professionalism

Is central to the services we provide to our clients.

We work hard to ensure that we provide specialist knowledge, competency, and accountability throughout all of the work we undertake.

Inrtegrity

Our clients trust us with their business.

From our stringent laboratory procedures to our submissions to regulatory bodies, our clients have peace of mind knowing that we will do the right thing by them, under all circumstances.

Ethics

Scientific regulatory affairs are underpinned by the ethical approach of the scientists and professionals working in this field. We are committed to upholding moral principles and working with our clients safety and improve public health.

Our people underpin these values and we are committed to making Inter Scientific a fantastic place to work. We aim to retain and employ top talent and develop grassroots, provide opportunities for young people and offering apprenticeships.


What you'll need:

• Background in electronic engineering, law or a science discipline
• A strong interest and desire to progress your career in medical device regulatory affairs.
• A basic knowledge and understanding of medical devices and their regulations.
• Exceptional communication and interpersonal skills, ability to build strong relationships internally and externally.
• Highly organised and detailoriented
• Selfmotivated and able to work independently whilst also being a collaborative team player

What you'll get from us:

• Competitive salary
• Paid enrolment on a TOPRA apprenticeship scheme (36 months)
• Time off to attend seminars and lectures totalling 20% of your working time.
• Support and guidance from expert colleagues
• Hybrid working arrangements in our stateoftheart, brandnew facility
• Eligibility to enroll in the company profit related bonus scheme
• Eligibility to enroll in the company health cash plan
• Company pension

Responsibilities:

• Monitor and stay current with the latest regulatory requirements and guidelines in each targeted country to maintain regulatory compliance.
• Maintain accurate and up to date records of all regulatory submissions and approvals, providing regular updates to management and colleagues.
• Drafting Documents
• SOP'S, Summary Documents
• Proof Reading Documents
• Procedures, Protocols, Reports, Blogs, Certificates etc.
• Communicating with Clients
• Exploratory Research
• Understanding different laws/regulations in areas that we don't do frequent work with.
• Ensuring adherence to statutory Operational Health and Safety (OHS) and best practice
• Complete training as directed by the Manager
• Gaining knowledge of the company Management System and working according to procedures
• Any reasonable activity requested by leadership and line manager
• Helping in other business areas (cosmetic, vape if requested)

Equality Statement

Important Information

• STRICTLY NO RECRUITERS_

A key requirement of this role is the ability to start work with us in time for the next enrolment onto the TOPRA apprenticeship for the next cohort.

We reserve the right to close this advert at any time.

Applicants must, at the time of applying, have the correct right to work documentation for the United Kingdom.


Job Type:
Apprenticeship


Pay:
From £24,000.00 per year


Benefits:

• Compan