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Regulatory Affairs Supervisor Latam
hace 3 meses
Regulatory Affairs Supervisor Latam (Medical Equipment)
Your role:
To formulate and implement the HPM Businesses and / or Markets long-range regulatory strategies for LATAM (Latin America).Main point of contact between BU, Market and Local Business Team for product registration preparation and renewals.
Create regulatory awareness level as determined within the organization.Supports implementation of simplified yet robust regulatory processes for registrations and labeling deviations across the HPM Businesses.
Introduce and implement the necessary regulatory processes and tools required to ensure first time right in submissions.
Ensure compliance to relevant regulations and other Regulatory Requirements and as required, guidelines and policies to all HPM products and operations are consistent with those regulations.
Lead the Planning, generation, and coordination of regulatory submissions for HPM product/solution licensing.Proactive stakeholder management in BU.Define and implement appropriate regulatory certifications for sites.
Ensures that all products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business and / or Market.
Formulates and recommends (changes to) policies and establishes procedures that affect immediate organization(s).Being part and execute the regulatory compliance guidance and regulatory streamline operational excellence between HPM groups /sites and Markets to ensure time to market on global initiatives especially related to new projects involving Regulatory for key decision makers.
Develop and maintain, execute and trackelicit regulatory requirements as per each country required for regulatory compliance and local regulations and tracking progress of project trackers for the markets impacted against planning, submissions and approvals deadlines You're the right fit if:(4 x bullets max)
- At least 8 years of experience as a regulatory manager for Latam in the medical equipment industry.
- You are resilient, proactive, teamwork and good listener.
- Bioengineering degree or similar studies.
- Advanced English
We are a health technology company.
We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve.
Do the work of your life to help the lives of others.- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply.
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