Senior RA Manager EMEA

THE COMPANY:

Specializing in microbiological diagnostics, this company made history by becoming the first in the world to design a fully automated system for reading and interpreting agar-based antibiograms.

Since its inception, it has continuously innovated, developing the first expert software for antibiogram interpretation, the first incubator-reader for agar-based antibiograms, and the only rapid medium for agar-based antibiograms.

Today, with several decades of innovation behind it, this company continues to lead its field, providing cutting-edge solutions for laboratories worldwide and remaining committed to being a trusted partner for the future.

THE OPPORTUNITY: 

Looking for a new opportunity in a company where work-life balance, flexibility, and a great atmosphere are top priorities?

Then this position might be for you!

You will be the Senior Regulatory Affairs Manager with a leading MedTech company. You'll have the chance to work on innovative and diverse medical devices, making a real impact in the industry.

As Senior Regulatory Affairs Manager, you'll be responsible for all regulatory activities in the EMEA region, leading a dedicated team and ensuring compliance across innovative products throughout their lifecycle.

You will supervise regulatory activities linked to the design, manufacture and distribution of custom-made products manufactured at their Saint Priest site.

This position will give you the chance to Develop European regulatory processes with other functions to ensure the compliance of regional activities.

RESPONSABILITIES: 

• As an expert in European regulations, manage requests from their legal entities and affiliated companies to support product design, change management, and post-market activities to ensure compliance.
• In the context of projects, support, in collaboration with internal stakeholders, the establishment of a regulatory strategy to meet applicable requirements and business needs.
• Actively participate in regional and global projects in close coordination with other functions, and particularly with global RA teams and the EMEA product registration team, to ensure that EMEA regulatory requirements are known and considered in projects.
• Manage all regulatory activities related to the import and distribution of their products and third-party products within the EU (including CH/UK).
• Supervise regulatory activities related to the design, manufacture, and distribution of custom-made Class I products manufactured at their Lyon site.
• Centralize, organize, and process regulatory requests as needed, and manage information accordingly.
• Serve as the primary contact for all regulatory requests related to European operations activities, such as repackaging or relabeling.
• Manage European regulatory surveillance in accordance with internal processes and ensure the appropriate regional application of new or revised regulatory requirements. Collaborate closely with global teams to ensure new or revised European regulatory requirements are appropriately incorporated into theirs quality system.
• Support the effective execution of FSCA and FCA in the EMEA region, from planning to report writing and follow-up.
• Conduct the necessary regulatory impact analysis for On-Hold meetings affecting the EMEA region.
• Serve as the primary internal regulatory contact for the EU region and act as a business partner to ensure compliance and continuity of activities conducted in EU countries.
• Establish and/or optimize processes to ensure regulated activities are conducted efficiently and in compliance with regulations and internal policies.
• Develop and maintain relevant instructions and procedures applicable to the activities and provide internal training.
• Support the teams development in performance, autonomy, organization, decision-making, and coordination. Encourage collaboration with other teams.
• Oversee onboarding and training of new team members and promote knowledge sharing.
• Support other team initiatives as needed.

REQUIEREMENTS : 

• Degree qualified with minimum 7 year-experience in Regulatory Affairs positions in medical device industry including a mandatory experience in design / manufacturing (i.e. design control) and a thorough knowledge of risk management principles in accordance with EN ISO 14971.
• Excellent knowledge of the regulatory and normative framework of Medical devices in Europe (MDD and MDR related).
• Ability to understand and interpret new requirements / regulations.
• Fluent in French and English (written and oral)
• Experience in team management

WHY JOIN?

• Flexibility: Enjoy a supportive work environment with flex office options that promote a healthy work-life balance

• Growth and Development: Work with a manager who is passionate about helping her team develop their skills and grow in their careers

• Leadership Opportunity: Manage managers, take on key responsibilities, and lead impactful projects

• Positive and Dynamic Environment: Thrive in a fun, collaborative atmosphere where innovation is at the heart of everything we do

If you are ready to take on this exciting challenge and contribute to this mission, please send your application to monia@talentssolutions.fr