Respironics Inc Looking for Quality & Regulatory Manager, Personal Health at United Arab Emirates Full Time

Job Title

Quality & Regulatory Manager, Personal Health

Job Description

Local lead for country transition of E2E programs related to Regulatory processes into the Markets OneQMS

Your role:

Regulatory Affairs

• Monitoring local regulatory landscape that impacts Philips and translate and implement these regulations into the Personal Health business.

• Provide continuous regional regulatory updates to applicable stakeholders and partner with Integrated Supply Chain and business regulatory teams to ensure end to end compliance.

• Engage in product, solutions and services development and lifecycle to ensure regulatory compliance.

• Lead regulatory compliance as appointed by the country legal entities to support changes in Regulations

• Lead Regulatory registration and company self assessments where required with Government Agencies as applicable for products, solution and services in the applicable country.

• Liaise with Post Market Surveillance team to ensure awareness of communication with Regulators and if required support any escalations.

• Build relations with Regulatory and Compliance SMEs with Philips and externally engaging Trade Associations and Regulators.

• Lead change in culture and facilitate regulatory compliance.

Quality Management

• Ensures traceability between Regulatory processes within Philips Excellence Process Framework and the Markets OneQMS

• The RA representative in projects to drive local compliance with the applicable country regulations and global alignment with Philips standards & policies.

• Provide Regulatory input and report out to the management team and management review

• Support with relevant regulatory inspections and quality management system audits and follow up with formal response to any findings that impact Regulatory.

You’re the right fit if:

• Bachelor or Master’s degree in a science, pharma or engineering direction or equivalent

• Demonstrable experience with Quality Management within household/medical device/Chemicals/Cosmetics/Toys regulatory domains

• Excellent verbal and written communication skills,demonstrated customer relation skills, strong skills and proven experience in complex stakeholders management in internal and external environments.

• Working knowledge of relevant Regulations (general product, medical devices, cosmetics, and preferably other applicable Regulations in Functional Chemicals, Toys, Batteries, Trade Compliance, Export Controls, Dangerous Goods, Information Technology Service Management, Healthcare Standards and Regulations).

• Ability to translate quality standards and regulation into operational process

• Able to analytically assess impact to the business and the ability to quickly understand and influence

• Fluent in English, verbal and written

About Philips
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 .
. Discover .
. Learn more about .

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 .