SRG partner with a global leader in the medical device arena. Due to continual business expansion, a Senior Quality and Regulatory Specialist is required to join their team in Denmark.
Working within their Commercial QARA division, this role will support across warehouse and distribution activities for centres in Godmanchester and Nordics, and third party warehouses and logistics centres. Fluency in English and Danish or Swedish is preferable.
- Support in Non-Conformance reports, Corrective Action Requests, change control actions and Quality Management Review.
- Provide support for design, execution and maintenance of quality system processes and Document Management System.
- Direct writing and review operating procedures to ensure compliance, efficiency and clarity.
- Coordinate locally the product quality holds and reconciliation of products as part of Field Actions.
- Manage internal audit schedule for the relevant sites and perform audits as required (including suppliers).
- Facilitate Quality and Regulatory induction training for the relevant sites.
- Interacting with and liaising with Competent Authorities as part of field action, vigilance and post-market surveillance activities.
- Manage and direct writing and review of regulatory processes and procedures to ensure compliance, efficiency and clarity.
- Establish and maintain an accurate filing system for Regulatory Affairs activities within each division and for each product as part of supplier management.
- Provide an accurate, timely and balanced Regulatory Affairs support to the business.
- Responsible for answering technical and regulatory enquiries from customers and colleagues to support their business activities (such as tenders submissions) and meet requirements.
- Participate in internal and external audits where Commercial Quality and Regulatory Affairs is involved.
- Review and approve advertising and promotional material; including Instructions for Use, conference material, and product claims for regulatory compliance.
Skills and Experience
- Strong working Knowledge of ISO 9001:2015.
- Solid knowledge of Medical Device Directive, Medical Device Regulation (European Union Medical Device Regulation (EU) 2017/745
- Quality and Regulatory experience or equivalent within a regulatory compliance function within a medical device setting/similar field
- Knowledge of Goods Distribution Practice for medical devices
- International experience within Regulatory Affairs is highly desirable, especially Sweden and Denmark
- Eligibility to work in Denmark
Please contact me: Holly.Evans@srgtalent.com or +447909 207 693 for a confidential discussion around your career in Regulatory Affairs/Quality Assurance within the Med Tech arena.
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