Regulatory Affairs Specialist

Functieomschrijving
Description of the company

Our client is a leading international company operating in a complex and highly regulated environment and is currently looking for a
Regulatory Affairs Specialist
for a renewable temporary assignment.

Role & Responsibilities

• Under supervision, coordinate, compile, and submit regulatory applications to competent authorities, notified bodies, regulatory agencies, and international business partners, including the preparation of key market international documents, including technical files.
• Work with Regional Head of Regulatory Affairs to ensure rapid and timely approval of new products and continued regulatory support of products marketed within and outside the Europe, including labelling guidance and adequate deliverables required for technical file and MDR requirements.
• Work to support and ensure regulatory compliance across Europe for a broad product portfolio including medical devices, consumer packaged goods, and cosmetics.
• Assist with the development of the Europe regulatory strategy collaborating with appropriate functional partners and contribute to business strategy.
• Support and make recommendations for projects by working closely with R&D and marketing departments to move projects from discovery to launch.
• Under supervision, evaluate proposed product modifications for domestic and international regulatory impact, completing regulatory assessments as needed in change control process.
• Ensure compliance with applicable Europe regulations and standards
• Oversee MDR and complaints; submit adverse events to the EU authorities and assess impact on other markets.
• Prepare necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
• Under supervision, prepare responses to health authority questions and other regulatory correspondence.
• Ensuring the maintenance of Regulatory related policies and procedures in quality management system.
• Update EDAMED database for Unique Device Identifiers as products are added and discontinued.
• Provide support to inspections/audits by government agencies and the notified body by producing requested documents or answering any inquiries for information.
• Review and approve promotional materials and labelling for impact to product classification.

Candidate Profile

EDUCATION

• Degree in regulatory affairs and/or in a scientific discipline relevant to human health
• Relevant trainings/diplomas on medical devices /cosmetics /food supplements/medicinal products

EXPERIENCE

• Minimum of 5 years of experience in Regulatory Affairs- related activities in life science industry, including product registration and regulatory support to product design & development projects
• Experience in vigilance management and regulatory framework survey in life science industry

COMPETENCIES

• Knowledge of EMEA applicable regulations related to :

- Medical devices - Cosmetic products - foods/food supplements - commodity products

• Analytical skills
• Strong interest in regulatory affairs
• Able to work in a multicultural environment
• Ability to independently identify compliance risks and escalate when necessary
• Problem solving skills
• Autonomous and proactive
• Team spirit
• Project management skills
• Fluent in English (both written and spoken)
• Computer literacy: MS Office