Global Regulatory Affairs Manager II
Global Regulatory Affairs Manager II - Fort Worth
9 month contract
W2 Pay Rate:
$55.00 - $59.28/hr
Position Overview
This position will independently provide tactical and strategic leadership on complex EU MDR projects within the Global Regulatory Affairs organization by actively compiling and authoring EU MDR-compliant STeD files.
Main Areas of Responsibilities
Independently lead development, remediation, planning, and authoring of EU MDR STeD files for Class IIa and IIb products.
Coordinate and lead cross-functional teams aimed at remediating MDD STeD files into MDR-compliant files, including Manufacturing, R&D, Pre-Clinical Safety, and Quality.
Lead project review meetings for management's oversight on progress and risks.
Requirements
Experience in a medical devices required.
Experience in MDR STeD file authoring required.
Develop and implement regulatory strategy aligned with business strategy.
Excellent communication and project management skills.
Preferred Skills/Qualification
Strong technical writing skills.
Strong project management skills.
B.S. required in related scientific discipline with a minimum of 5 years of regulatory experience
MS degree and 3 years of regulatory experience.
PhD and 1 years of regulatory experience.
Opportunity is Calling, Apply Now!
What's In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
Note:
Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https:
//www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.Estimated Salary: $20 to $28 per hour based on qualifications.
9 month contract
W2 Pay Rate:
$55.00 - $59.28/hr
Position Overview
This position will independently provide tactical and strategic leadership on complex EU MDR projects within the Global Regulatory Affairs organization by actively compiling and authoring EU MDR-compliant STeD files.
Main Areas of Responsibilities
Independently lead development, remediation, planning, and authoring of EU MDR STeD files for Class IIa and IIb products.
Coordinate and lead cross-functional teams aimed at remediating MDD STeD files into MDR-compliant files, including Manufacturing, R&D, Pre-Clinical Safety, and Quality.
Lead project review meetings for management's oversight on progress and risks.
Requirements
Experience in a medical devices required.
Experience in MDR STeD file authoring required.
Develop and implement regulatory strategy aligned with business strategy.
Excellent communication and project management skills.
Preferred Skills/Qualification
Strong technical writing skills.
Strong project management skills.
B.S. required in related scientific discipline with a minimum of 5 years of regulatory experience
MS degree and 3 years of regulatory experience.
PhD and 1 years of regulatory experience.
Opportunity is Calling, Apply Now!
What's In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
- Medical, Dental & Vision Benefits
- 401K Retirement Saving Plan
- Life & Disability Insurance
- Direct Deposit & weekly ePayroll
- Employee Discount Programs
- Referral Bonus Programs
Note:
Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https:
//www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.Estimated Salary: $20 to $28 per hour based on qualifications.
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