Regulatory Affairs Manager, Hospital Patient Monitoring META

Job Description

Job TitleRegulatory Affairs Manager, Hospital Patient Monitoring METAJob Description

Job title:

Main point of contact between BU, Market and Local Business Team for product registration preparation and renewals.

You are responsible for

• 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 track elicit 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:

Education: Bachelor’s degree.

•Experience: At least preferably 6 years of Regulatory Affairs experience in medical industries or pharma sectors.

•Excellent command of English and Arabic is required.

•Be familiar with ISO 13485, ISO 9001 ,MDD 93/42/EEC or EU-MDR.

•Excellent organization and coordination skills.

About Philips
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.