Senior RA Manager EMEA
il y a 1 semaine
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 agarbased antibiograms.
Since its inception it has continuously innovated developing the first expert software for antibiogram interpretation the first incubatorreader for agarbased antibiograms and the only rapid medium for agarbased antibiograms.
Today with several decades of innovation behind it this company continues to lead its field providing cuttingedge 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 worklife 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. Youll have the chance to work on innovative and diverse medical devices making a real impact in the industry.
As Senior Regulatory Affairs Manager youll 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 custommade 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 postmarket 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 thirdparty products within the EU (including CH/UK).
- Supervise regulatory activities related to the design manufacture and distribution of custommade 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 followup.
- Conduct the necessary regulatory impact analysis for OnHold 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 decisionmaking 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 yearexperience 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 worklife 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
Remote Work :
No
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