Regulatory and Compliance Officer

**Regulatory and Compliance Officer**

ITH Group is a growing group of privately owned healthcare and pharmaceutical related business. Within the group sits ITH Healthcare, ITH Systems and our largest group company ITH Pharma which specialises in the provision of Parenteral Nutrition, Chemotherapy and CIVAS. Our team provides flexible services with batch and bespoke items for adults, paediatrics and neonates to both NHS and private hospitals.

**Role**

We are recruiting for a Regulatory and Compliance Officer to To professionally support the provision of regulatory compliance to MHRA, ISO and MDR regulations across the group companies

**Duties will include**:

- To ensure ongoing compliance with ISO 13485 and other relevant standards and to assist in the development of parity between the requirements of ISO and MHRA where relevant. This includes harmonising of internal SOPs and other quality management standards.
- To ensure that management and processes are kept up to date to reflect the most current legislation.
- To work with departmental heads of group companies to assist in co-ordinating regulatory affairs as they pertain to MHRA and ISO certificates held by the company.
- Responsible for ensuring the smooth running of activities related to regulatory compliance within the UK (and the EU where applicable), as well as providing regulatory expertise for the projects in which you are involved.
- Liaise with regulatory authorities with regards to inspections and any issues concerning MDR licences and ISO certificates.
- Co-ordinate with business partners in strategic projects to ensure appropriate training/expertise is available for compliance purposes.
- The role will also involve the responsibility for our own Medical Device and maintainingthe technical file and procedures.
- Accountable for Post Market Surveillance (PMS) activities in the UK (and other countries as required), specifically Product Field Safety Corrective Actions (FSCA), including notification, efficient and timely execution, and reporting

**Applicants**

Applicants must already be in a Regulatory position and have full up to date knowledge and well as extensive practical experience gained within the medical device or pharmaceutical industry within regulatory and compliance.

You will be working with ISO13485 currently relating to Class 1 medical devices and be used to working within a GMP environment.

Experience with ISO17025 and the CQC is desirable but is not essential.

You will have a flexible and adaptable approach to your work and be used to working to tight deadlines. You will also have a logical approach to your role and have strong problem identification and solving skill.

Ideally you will be a member of TOPRA and have worked your way up through the quality (within pharma or medical devices) side of the business.

This is a full time role and we will consider a hybrid working model.

**Salary**

In return, we pay between £60,000 and £70,000 per annum.

**Benefits include the below**:

- Private Healthcare
- Pension
- 24 days holiday a year plus bank holidays.
- Regular company activities which include social events, free lunches and treats, and inclusion in company raffle to event prizes for numerous sporting and music events.
- Access to our in-house Health Clinic which includes our in house Doctor
- Access to our in house Pharmacy + Pharmacy allowance

**Job Type**: Permanent

**Salary**: £60,000.00-£70,000.00 per year

**Benefits**:

- Private medical insurance
- Work from home

Schedule:

- Monday to Friday

Ability to commute/relocate:

- London: reliably commute or plan to relocate before starting work (required)

**Experience**:

- Regulatory Affairs: 2 years (required)

Work Location: Hybrid remote in London