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Quality and Regulatory Affairs Manager

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

Ireland

Offer summary

Qualifications:

Life Sciences / Regulatory Sciences degree, Experience as a Quality Professional, Experience as a Regulatory Professional, Experience with medical devices in related roles, Familiarity with ISO frameworks and MDR.

Key responsabilities:

Create and maintain Technical Files for Class I and II devices
Drive regulatory strategy for domestic and international markets
Manage supplier control and audits for new products
Lead continuous improvement of Quality System processes
Provide training on quality and compliance matters

SCOPE Eyecare & Healthcare Pharmaceuticals SME https://www.aboutscope.net/

51 - 200 Employees

See more SCOPE Eyecare & Healthcare offers

Job description

We are currently recruiting for a Quality Assurance and Regulatory Affairs Manager to join our Quality and Regulatory Affairs team!

A hybrid role working across both Quality and Regulatory Affairs, building processes suitable for a fast-growing company, partnering to accelerate innovation and R&D, and maintaining standards for current products.

The role requires a broad understanding of regulatory requirements across multiple legislations and geographies. It also requires an understanding of working within a QMS framework to support multiple product types and classifications.

Regulatory:

Technical File creation and maintenance for Class I and II devices to MDR and UKCA.
Medical device dossier submissions and liaison with NB’s and HA’s.
Working in partnership with R&D in new product design and modifications/line extensions.
Performing post market surveillance activities including clinical follow up and periodic safety reports.
Defining regulatory strategy for domestic and international markets.
Ensuring compliance where applicable to relevant domestic and international standards e.g. ISO 13485, MDD 93/42/EEC, FDA CFR 21, MDR EU 2017/745 and UK MDR 2022 SI 618.

Quality:

Ownership of supplier control for new products, including creation and implementation of supplier review cycles e.g. Quality Technical Agreements, audit schedules.
Leading external audits and driving associated actions to completion.
Creating and managing CAPA, NC, change control, including conducting investigations to drive root cause.
Ensuring Quality System processes are lean, compliant, user-friendly and are well understood throughout the organisation.

Cross functional:

Provide expert guidance, support and training on quality and compliance matters to the functional teams.
Enhance a compliance culture throughout the organisation.
Carry out training and communication activities with staff to ensure adequate understanding of quality systems and regulatory requirements.
Drive continuous improvement and best practice

Qualifications

Required:

Life Sciences / Regulatory Sciences degree.
Experience of working as a Quality Professional.
Experience of working as a Regulatory Professional.
Experience working with medical devices either in a quality or regulatory role.
Experience of working within and managing a quality ISO framework e.g. ISO 13485, ISO 9001.
Experience of working with / within MDR.

Desirable:

Experience with licenced medicines in the UK or EU.
Experience with ophthalmic products in the US.
Experience with cosmetics and food supplements.
Experience with sterile products.
Experience of creating / maintaining clinical evaluation and biological evaluation reports.
Lead auditor (external).