Kaztronix
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http://www.kaztronix.com
http://www.kaztronix.com
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Regulatory Project Manager
Job Description
We're currently seeking a dynamic and experienced Project Manager (Medical Device Regulatory). The role can be offered as a full time or part time opportunity. If you're a results-driven professional looking to make a meaningful impact every day, this is the place for you! Work alongside like-minded, self-directed individuals in a collaborative and professional environment.
Responsibilities
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
Responsibilities
- Manage and coordinate revisions of our quality management system (QMS) documentation for product security, adhering to FDA and legal requirements.
- Develop project timelines, scope documents, stakeholder, and communication management plans.
- Utilize excellent interpersonal skills, comfortable with Teams and Outlook, and experienced in remote work.
- Assist in managing multiple engineering projects, ensuring effective resource utilization and meeting project deadlines.
- Evaluate and authorize changes affecting project scope, budget, or timeline.
- Lead projects, monitor progress, identify and resolve operational problems, and minimize delays.
- Manage ongoing relationships and communication plans.
- Define and manage project scope, budget, and schedule. Identify critical paths, constraints, contingencies, and risks to achieve project and business objectives.
- Communicate project status and escalate risks to stakeholders.
- Deliver all technical and business requirements, providing Lessons Learned, Best Practices, and Resource management recommendations.
- Bachelor's degree required;scientific or engineering field preferred.
- 6+ years of experience with a successful track record in Medical Device Regulatory projects.
- Project Management experience is a must.
- Background understanding of RIMS.
- Ability to communicate and influence at all organizational levels.
- Strong organizational, problem-solving, and analytical skills.
- Proficiency in MS Office Suite, with strong Excel skills. PMP/PMI Certification Required.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
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