Department: Quality and Regulatory Affairs (QARA) – Europe

Role reports to: President Europe / Senior Director International QMS and Regulatory Affairs, USA

Location: Châteaubriant, France

Purpose
With the support of the entire European quality assurance and regulatory affairs (QARA) team, the Director Quality and Regulatory Affairs - Europe plays a crucial role in ensuring adherence to quality management system standards, product and process conformity, medical device safety, sterility, and regulatory compliance for all products manufactured under Medline International France's legal responsibility. Additional responsibilities will extend to products distributed by Medline International (MIBV), as well as all quality assurance and quality control (QA/QC) requirements related to warehousing and distribution within Europe.

In this role, you will be an integral member of the Medline Europe senior management team. You will report directly to the President of Medline Europe, with dotted line reporting to the Senior Director International QMS and Regulatory Affairs in the USA. This is a highly collaborative position which serves as a key business partner and actively participates in defining and executing Medline Europe's short-term and long-term strategic goals, while effectively managing financial budgets for QARA operations in Europe.

In collaboration with management, this position also plans, prepares, and implements an efficient organisational structure that supports high employee engagement and career development.

How can you help us?

• Provide leadership, QARA support, and strategic direction to international QARA teams.
• Serve as the deputy management representative and materiovigilance contact for Medline International France.
• Manage the quality management system (QMS) of the manufacturing, warehouse and distribution sites located throughout Europe and the UK.
• Ensure that sterilisation activities under the direct responsibility of the European Organisation comply with all quality and regulatory requirements.

Additional responsibilities:

• Collaborate with the management team to develop and implement strategic business plans.
• Work with QARA management to define and manage the QARA structure for Medline Europe.
• Set priorities and objectives, and develop appropriate procedures and processes for QARA activities in compliance with regulations.
• Develop and implement appropriate procedures and processes to perform all QARA activity in compliance with the appropriate regulations.
• Work actively with the QARA teams worldwide on Medline harmonisation activities;
• Work with relevant business partners on the development, approval and launch of new products, materials and sources.
• Assure proper design control processes are followed and documented in accordance with the QMS and relevant regulations.
• Coordinate the validation of new components for custom surgical packs.
• Identify areas and processes for improvement; coordinate implementation of improved processes.
• Coordinate and work with the USA regulatory affairs team on creation and maintenance of technical files; submit design dossiers to the appropriate notified body.
• Obtain required quality/EC Certificates. Ensure products are properly registered for sale with the competent authorities in relevant countries.
• Coordinate post-market surveillance activities in collaboration with the Medline Regulatory Affairs Specialist and the competent authorities.
• Ensure appropriate investigations regarding customer complaints and adverse events reported in the market.
• Manage, maintain and communicate reports concerning medical complaints, recalls and other field actions.
• Provide guidance and mentoring to people leaders; lead and coach others through organisational changes. Offer coaching and feedback to enhance organisational capabilities.
• Provide timely, candid, and constructive performance feedback to employees. Help in developing employees to their fullest potential and create opportunities for career growth. Recognise and reward employees for their accomplishments.
• Address technical, quality, or regulatory questions from customers or related to tenders effectively.
• Ensure Medline's active participation and representation in international meetings organised in the medical device industry (MedTech - EU, Switzerland).
• Facilitate Medline's involvement in working groups focused on the creation and modification of standards related to medical devices as appropriate.

Are you our match?

• University degree required; engineering or related sciences preferred
• 7-10 years of quality assurance and regulatory affairs responsibilities in the medical device industry
• Excellent knowledge of the ISO 13485; MDR 2017/745, MDD 93/42/EEC, and related regulations
• Management experience; proven ability to develop and lead a highly competent team
• Proven ability to work collaboratively across functional departments
• Excellent written and oral communication skills, with fluency in English and French
• Proficiency in process improvement or lean six sigma training is a plus.

Please note that this recruitment process is being managed by an external recruitment agency. By applying for this
position, you acknowledge and understand that your application will be shared with the external agency, who will
be responsible for screening and shortlisting candidates before they are presented to us.