Medical Devices Regulatory Team Lead

**Medical Devices - Team Lead**

Location

Carrer de Lleó XIII, 7, Planta 2a, Barcelona

**Background**

Inter Scientific is involved in providing regulatory support and product analysis to the; pharmaceutical, cosmetic, vape and food industries. The company has grown rapidly since its inception with a strong focus on a high quality of work and good customer service. To date, the companies’ activities have been focused in the US and UK primarily due to language and ease of doing business, though the company has a small European client base.

With the UK exiting the EU, a number of regulatory changes have been created, giving rise to the need for a European-located office. This relates primarily to the provision of professional services to the medical device and cosmetic industries, where the company acts as Authorised Representative (Medical Devices) and Responsible Person (Cosmetics).

The company has established itself in Spain in 2020, though due to the COVID-19 pandemic, the establishment of a physical team in Spain has been delayed. The company is now recruiting its first team based in its office in Barcelona.

**Purpose of the Role**

The company has an exciting opportunity for a Medical Device - Team Lead to join the regulatory department. This role will report directly to the Regulatory Affairs Manager in the UK and will be responsible as the first point of contact for all clients based in the EU about medical device services. The primary focus of the role will be to develop the European client base of the company in Spain & France.

**Day-to-day activities**

As this is the first medical device-related role of the company’s Spanish office, the day-to-day activities are likely to be varied and change throughout the course of employment. As the role develops the Medical Device team lead will work closely with the UK team to ensure seamless service offerings to our clients internationally.

The Medical Device Team Lead will be responsible for the regulatory compliance of our clients as the PRRC (Person Responsible for Regulatory Compliance) and fulfil the role of AR (Authorised Representative).

**Primary Responsibilities**:

- Developing sales in the EU for medical devices regulatory services.
- Developing client relationships.
- Assisting in the development of new services based on client needs.
- Acting as Person Responsible for Regulatory Compliance (PRRC).
- Assist in the design and development of Technical Documentation.
- Support with UDI compliance.
- Support with QMS (ISO 13485) compliance.
- Manage regulatory affairs responsibilities: product registration to establish regulatory strategies, authoring and/or reviewing regulatory documents (technical files, submissions), monitoring status of registrations, providing support for currently
- marketed products, including review and update of product/ manufacturing process changes, supplier changes, new and revised reports, and product labelling
- Review promotional material and labelling to ensure applicable regulatory requirements are met.

**Additional Responsibilities**:

- Supporting sales on onboarding new clients.
- Representation company in medical device related matters.

**Knowledge Skills and Experience**:
**Essential**
- Fluency in English and Spanish and 3rd European language (French or German)
- Experience in professional/services sales
- Knowledge of the medical device
- Over 4 years experience within the medical devices industry

**Desirable**
- Knowledge of US medical device regulation
- Experience in client-facing role

**Qualifications/Experience**:

- A Bachelor's degree is preferable but not essential
- Minimum of 4 years regulatory affairs experience without a degree
- Masters in Medical Devices

**Screening**

**Responsible for staff/equipment**
- Company desktop/laptop

Reporting to:

- Regulatory Affairs Manager
- CEO

Tipo de puesto: Jornada completa

Salario: 22.000,00€-26.500,00€ al año

Beneficios:

- Flexibilidad horaria
- Formación en certificaciones profesionales
- Jornada intensiva en verano

Horario:

- De lunes a viernes

Retribución complementaria:

- Bonus por objetivos

Experiência:

- Medical Devices: 4 años (Obligatorio)