The future is what you make it.
When you join Honeywell, you become a member of our global team of thinkers, innovators, dreamers and doers who make the things that make the future.
That means changing the way we fly, fueling jets in an eco-friendly way, keeping buildings smart and safe and even making it possible to breathe on Mars.
Working at Honeywell isn’t just about developing cool things. That’s why all of our employees enjoy access to dynamic career opportunities across different fields and industries.
Are you ready to help us make the future?
Be a part of our global Regulatory Compliance Leadership Team that applies its expertise and knowledge in finding innovative, cost-effective means to improve regulatory compliance, quality output and continuous improvement. Specific responsibilities include but are not limited to:
Support new product development/modifications projects.
Subject Matter Expert for the business relative to FDD regulatory
Ensure compliance assigned projects and for applicable manufacturing sites, regarding design, development, validation, commercialization of products throughout the product life cycle.
Ensure timely submissions such as Premarket Approvals: and 510K, CE marking applications, and technical documentation, to obtain domestic filings.
Ensure European regulatory approvals are submitted in timely manner
Interpret and/or evaluate proposed registration requirements for medical devices and advise on the impact of such regulations and risks to the company.
Ensure proper review and approve device labeling and advertising materials for compliance with regulations and product filings.
Maintain regulatory intelligence and compliance through continuous monitoring of regulatory functions; identify risks, mitigation, and resolution strategies.
Evaluate, develop, implement business process improvements.
An integral part of this role is to build a relationship with the FDA, Notified Bodies and international regulatory authorities.
Verify compliance with site QMS such as ISO 13485
Develop high powered team that can respond quickly to business needs in bringing new products to market,
Monitor VE, CE, NPI projects to ensure compliance is complete and on-time
Ensure supplier cGMP’s practices are maintained at selected sites via site audit
YOU MUST HAVE
Bachelor’s in Engineering
5+ years’ experience leading FDD compliance including FDA and EUMDD
5+ years experience global manager, capable of interfacing with senior executives and clear track record in developing high performing teams.
5+ years experience working directly Notified Bodies and agencies including FDA.
MBA or Masters in Technical Discipline
Experience working with EU MDR, MDSAP and ISO 13485
Honeywell is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.