Honeywell FDA Regulatory Engineer in Mexicali, Mexico
FDA Regulatory Engineer
Innovate to solve the world's most important challenges
The Regulatory Engineer will have responsibility for the regulatory submissions, regulatory compliance, regulatory advice and counseling, advertising and promotion review and all relevant product registrations. An integral part of this role is to build a relationships with the FDA, notified bodies and international regulatory authorities.
· Submit on time certification renewals for the E&F business, and the yearly FDA site renewal.
· First Aid with Drug Reregistration Project.
· Provide on time documentation requested by customer and governmental agencies.
· Ensure GMP’s practice are maintained in the facilities and DCs where are storage drugs or medical devices.
· Preparation and submission of all product approval applications.
· Support Customs FDA holds at border crossing.
· Review compliance database for customs.
· Provide interpretive guidance on regulatory requirements.
· Keep all stakeholders apprised of expected changes to the regulatory landscape affecting the performance of existing, and new products.
· UDI Maintenance Project and Continuation of Business
Expected Areas of Competence
· Possess strong oral and written communication skills and proven ability to generate submissions.
· Strong knowledge of FDA requirements relating to regulatory submissions and clinical investigations.
· Candidate should be interested in working in a multicultural, fast-paced, dynamic start-up company environment.
· Candidate must be energetic, organized, and flexible to quickly adjust priorities as needed for achievement of company objectives.
20 Idea generation
20 Brainstorm solutions
20 Continuous improvement
20 Risk analysis
20 Coordinate resolution
YOU MUST HAVE
· Bachelor degree in Mechanical / Safety / PPE related subject matter or Associate degree with 5-10 years of compliance safety related experience including quality control, quality assurance, and product certification
· Knowledge of CE (Europe Regulations) and product testing; Project Management Skills
· Ability to work in and across functions
· Experience in product safety regulations
· International Compliance Experience (ISO standards) 13485, 17000 (Labs)
· Design for manufacturing experience
· Experience and knowledge of the different manufacturing processes
· Lean Manufacturing or Six Sigma training
· Green Belt (plus)
- Hands on work ethic
- Out of box thinking
- Provide clear and concise communications
- Greenbelt Certified
- Proficient computer skills
- Regulatory experience
- Knowledge of six sigma tools
- Ability to partner with others on projects
- Understanding of quality processes
Exempt Five-Year Plan
- Some Travel Required
- Continued Professional Development
- Job ID: req113292
- Location: Mexicali, BC 21385 MEX
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, or veteran status.
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.
For more information on applicable equal employment regulations, refer to the EEO is the Law poster .
Please refer to the EEO is the Law Supplement Poster & the Pay Transparency Policy .
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