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Project Manager, Regulatory Affairs - Device Labeling

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Job Details
Job Order Number
JC149085231
Company Name
Randstad
Physical Address

Deerfield, IL 60015
Job Description

Project Manager, Regulatory Affairs – Device Labeling

job details:

+ location:Deerfield, IL

+ salary:$70 – $77.72 per hour

+ date posted:Friday, October 4, 2019

+ experience:5 Years

+ job type:Contract

+ industry:Professional, Scientific, and Technical Services

+ reference:30087

job description

Project Manager, Regulatory Affairs – Device Labeling

job summary:

As the world’s largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you’re looking to be a part of an impactful team, you won’t be disappointed!

location: Deerfield, Illinois

job type: Contract

salary: $70.00 – 77.72 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

+ In collaboration with cross functional teams, the incumbent provides guidance and subject matter support to RA project teams to facilitate regulatory compliance for EU MDR (EU Medical Device Regulation) in the most effective risk-based method. Provides leadership and guidance and subject matter support to offshore and onshore project contractors.

+ In collaboration with cross functional teams, will be responsible for driving global device labeling initiatives to support the EU MDR remediation project objectives.

+ Develop and execute global regulatory labeling strategies and plans for complex projects including new products and ongoing global compliance for products already on market. Understand and incorporate key labeling requirements and best practices into global labeling strategies.

+ Formulate and drive global labeling traceability requirements within project and product teams.

+ Represent or lead the RA labeling function on assigned cross-functional project teams and projects to develop global device labeling requirements and labeling content. Contribute independent ideas and help guide the overall effectiveness of the cross-functional labeling team.

+ Monitor applicable global regulatory and labeling requirements; assure compliance with Company and external standards and help drive implementation across functions and projects.

+ Effectively assess impact of emerging global labeling regulations and requirements and help implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance.

+ Effectively perform labeling gap analysis and propose solutions. Develop and document sound regulatory decisions and justifications.

+ Develop and maintain effective cross-functional partnerships and network within RA and key stakeholders including Marketing, R&D, QA, Supply Chain to drive key EU MDR labeling strategies and initiatives.

+ Ensure project teams and business objectives and deliverables are aligned with project regulatory labeling strategy

+ Lead group of regulatory professionals in labeling gap assessments to EU MDR requirements and the further development of labeling requirements documents per MDR project timelines

+ Provide direct supervision and mentoring of project team members during the project. Provide project performance feedback to the team members supervisor/manager

+ Assist in the formulation and execution of regulatory strategies/ project plans

+ Develop and communicate guidance for EU MDR, global and regional regulatory and customer labelling requirements.

+ Monitor evolving regulatory requirements and ensure compliance programs are appropriate and meet requirements

+ Perform labeling gap assessments and provide remediation guidance and strategies

+ Develop and review labeling requirement specifications for remediated products

+ Monitors work output of contractors to define and execute additional training

+ Develop and report periodically metrics for assigned work projects.

+ Assist in the formulation and execution of regulatory strategies/ project plans

+ Develop and communicate guidance for EU MDR, global and regional regulatory and customer labelling requirements.

+ Monitor evolving regulatory requirements and ensure compliance programs are appropriate and meet requirements

+ Perform labeling gap assessments and provide remediation guidance and strategies

+ Develop and review labeling requirement specifications for remediated products

+ Monitors work output of contractors to define and execute additional training

+ Develop and report periodically metrics for assigned work projects.

qualifications:

+ Bachelor’s degree in biological sciences, engineering or related field preferred.

+ Five or more years’ experience in medical device Regulatory Affairs. Direct experience with global device labeling will be an advantage.

+ Minimum of five years professional experience managing people or projects.

+ Regulatory Certifications such as RAPS a plus

+ Extensive knowledge of medical device regulatory requirements for the EU MDR (Medical Device Regulation), and other global Device Labeling requirements.

+ Ability to identify and communicate potential compliance issues and escalate as necessary.

+ Prudent risk taker.

+ Strong business acumen.

+ Strong oral, written communication and presentation skills.

+ Demonstrated interpersonal skills including strong negotiation and facilitation skills.

+ Demonstrated leadership skills and experience with coaching others.

+ Strong project management and organizational skills.

+ Proven track record on delivering large scale projects.

+ Ability to manage complex projects and timelines in a matrix team environment.

skills: Project Management, MS-WORD, MS-EXCEL, GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions

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.


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