Manager, Regulatory Affairs - (US-NY-Rochester) 25%

Manager, Regulatory Affairs - (US-NY-Rochester)

Compensation: $80K - $98K / Year
Minimum Education: Bachelors
Job Type: Full Time
Jobcode: B4405BRJA
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Experience Required : 5 - 10 years
PAID RELOCATION AVAILABLE
Provide Regulatory Affairs support to manage product development projects to include 510(k), PMA, IDE, label/advertising review and other Regulatory Affairs support activities.

Job Duties:
Prepare US and non-US product submissions such as 510(k), PMA, IDE, CE technical file. This requires participation in product development teams as well as to review, analyze and comment on technical reports.

Review, approve, and provide guidance for labeling and advertising of B&L device products. Counsel technical and business groups to establish direction, based on available data and regulatory considerations.

Provide review and guidance of failure Investigations and corrective actions referred to Regulatory Affairs. Provide guidance on Regulatory compliance.

Review and approve policies and procedures.

Interact with US and non-US government officials on product approval and compliance issues.

Provide input and comment to regulations and standards which may affect B&L device products.

Candidate Must Have :
* BA/BS degree in a technical or scientific discipline. Advanced degree or additional professional training would be of value.
* Experience: Minimum 5-7 years experience in Regulatory Affairs with a demonstrated capability and experience preparing submissions for US Class II/Class III medical devices, as well as non-US medical device products. 10+ years experience in the medical device or drug industry desired. Knowledge of medical device or drug GMPs desired.
* Special Skills: Must have excellent communication, organization, and writing skills.
* Specialized Training: Computer literate with general office software and internet use.

Email resume in Word to TheBigGameHunter@cisny.com. Please include the job code for the position with your resume.

NO VISA TRANSFERS. NO OVERSEAS RESUMES. NO 3RD PARTIES.

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Jeff Altman, The Big Game Hunter
Concepts In Staffing
9 East 37 Street
New York, NY 10016

J2ME Developer - (US-NY-New York)

J2ME Developer - (US-NY-New York)

Compensation: $100K - $120K / Year
Minimum Education: Bachelors
Job Type: Full Time
Jobcode: VNRJA7
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Reporting to the Director of Development the J2ME Lead Developer position is established to envision product development and manage projects through completion. She/he analyzes, designs and develops software enhancements and new modules. Manages development project from initial design through testing while providing strategic management direction.

Primary Responsibilities
• Designs, develops and modifies programs, including prototypes. Responsibility and ownership of the framework/data/protocol
• Working with the Software Architect to introduce, establish and maintain coding techniques
• Other areas of development may include developing the Google Android version of this application
• Mentoring junior staff in software development techniques
• Contributing to estimating efforts and to roadmap planning with Software Architect
• Provides status reporting to the Development Director and designated Project Manager.
• Exercises independent judgment and discretion in overall project management. Prioritizes, plans and tracks project progress.
• Advise on design and architectural decisions
• Interact with PM on project progress and challenges
• Performs other job-related duties and responsibilities as may be assigned by R&D Director.
• Provides support regarding product development to internal departments
• Evaluates employee performance, sets expectations and goals for team, recruits, develops and trains staff.

Knowledge and Skills Required
• Required, Bachelor of Science in Computer Science or Information Systems, or equivalent experience
• 5+ years experience with full lifecycle software development from conception through to maintenance activities
• 3+ years experience working on a commercial j2me application as a lead or expert developer
• Excellent working knowledge with portability issues between the different j2me platforms
Demonstrated ability to delegate and oversee software development activities
• Demonstrated ability to deliver high quality, easily maintainable code in a production software environment
• Experience with a wide variety of software architectures (stand alone, client/server, web server, thin and thick clients)
• Strong experience with software architecture and design patterns.
• Strong conceptualization and abstraction skills
• Ability to enforce code re-use across multiple platforms and applications

Knowledge and Skills Required
• Experience with mobile application delivery and provisioning
• Experience with process and application reverse-engineering
• Experience in software analysis and design
• Ability to communicate effectively both verbally and in writing
• Demonstrated ability to lead and mentor junior development staff
• Has experience using professionally one of the following code converter

o JavaGround Xpress Suite
o Mobile Distillery Celsius
o J2ME Polish
o Innaworks Alchemo
o Metismo Bedrock

Email resume in Word to TheBigGameHunter@cisny.com. Please include the job code for the position with your resume.

NO RELOCATION. NO VISA TRANSFERS. NO OVERSEAS RESUMES. NO 3RD PARTIES.

To receive a complimentary subscription to my job search ezine, No B.S. Job Search Advice, go to www.jeffaltman.com to subscribe. Receive tweets about consulting assignments; subscribe to USConsulting on Twitter

Engineering Team Leader - (US-FL-Tampa)

Engineering Team Leader - (US-FL-Tampa)

Compensation: $60K - $76K / Year
Minimum Education: Bachelors
Job Type: Full Time
Jobcode: H4684JA

If not you, would you know someone???  I will pay a finders' fee if you refer someone who is hired.

Experience Required : 3 - 5 years
PAID RELOCATION AVAILABLE

Supervises Set-up Mechanics(SUM) who operate filling and packaging equipment and ensures all production line machinery is properly set-up and maintained at all times. Maintain production area as to prevent cross-contamination and sterility problems. Responsible for all assigned lines: spare parts ordering, machine performance, preventative maintenance, parts specifications, spare parts inventory, work orders, shutdown scheduling, manual and set-up points/sheets. Properly documents all activities. Support the installation and troubleshooting of equipment as needed. Assign work to Set-Up Mechanics, provide training, participate in cross-functional activities, review work of Set-Up Mechanics and train as necessary. Implement programs to standardize and minimize production changeovers and equipment downtime. Analyzes data to make improvements to material variance and line efficiencies. Report strategies and results to management.Oversees preventative maintenance, repairs, and line changeovers for a three shift operation.

Qualifications:
BS in Mechanical or Electrical Engineering preferred or related studies. Aseptic Experience Preferred. Minimum of 5 years experience in supervising a Maintenance or Production Set-up group. Supervision experience in an FDA regulated facility preferred or related field and project management experience.Possess mechanical and electrical skills, troubleshooting and repair of high speed filling and packaging equipment. Must be able to handle multiple tasks. Possess excellent time management and documentation skills. Have strong communication skills, and able to take and give directions. Must have proficient computer, mathematical, and written skills. Interaction with all levels of the organization. Able to work quickly and under pressure. Must be detail oriented and quality conscious.

Email resume in Word to TheBigGameHunter@cisny.com. Please include the job code for the position with your resume.

NO VISA TRANSFERS. NO OVERSEAS RESUMES. NO 3RD PARTIES.

To receive a complimentary subscription to my job search ezine, No B.S. Job Search Advice, go to www.jeffaltman.com to subscribe. Receive tweets about consulting assignments; subscribe to USConsulting on Twitter