Supports the development of process for specifying and executing C&R are adequate to ensure the expectations of local key stakeholders are met.
Facilitates C&Rs by ensuring the coordination and or creation of C&R file documentation, C&R file completion and C&R responses.
Prepares key documents such as Health Hazard Evaluation documents, product C&R files and various internal reports.
Ensures alignment between risk assessment and management documentation and C&R files.
Monitor and report on metrics on the C&R KPI's and generation of periodic reports.
Markets:
Submits FSN Communication to the Competent Authorities and or other regulatory agency as required by Country/Market
Monitors KPI and escalate when needed to ensure timely closure.
May support the resolution of FCO prioritization in local Markets in alignment with C&R priorities across Philips.
A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in a creative way.
Has complete knowledge of company products and services.
Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company. Often must lead a cooperative effort among members of a project team.
Works on issues of diverse scope where analysis of situation or data requires review of relevant factors, including an understanding of current business trends.
Follows process and operational policies in selecting methods and techniques for obtaining solutions.
Acts as advisor to subordinate(s) to meet schedules and/or resolve technical problems.
Develop and administer schedules, performance requirements. - Has budget responsibilities
location: Pittsburgh, Pennsylvania
job type: Contract
salary: $55 - 60 per hour
work hours: 8am to 4pm
education: Bachelors
responsibilities:
EDU & Training Requirements: Bachelor's degree Basic understanding of global medical device regulations such as ISO 13485, FDA QSR, 21 CFR 806 or local regulatory reporting requirements.
Experience required: 4-6 years experience. Medical Device and/or other regulated industry (Pharma, IVD) experience
qualifications:
- Experience level: Experienced
- Minimum 5 years of experience
- Education: Bachelors (required)
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
