Regulatory Affairs Associate
Regulatory Affairs Associate
DivIHN Integration Inc
Abbott, TX
See who DivIHN Integration Inc has hired for this role
DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
Visit us at https://divihn.com/find-a-job/ to learn more and view our open positions.
Please apply or call one of us to learn more
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Meghna at (224) 369-4230
Rashi at (630) 847-1027
Title: Regulatory Affairs Associate
Location: Abbott Park, IL
Duration: 9 Months
Description
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
Review/approval of engineering study protocols/reports and validation study protocols/reports.
Review and approval of manufacturing changes for Class III implantable medical devices.
May require an advanced degree and 5-8 years of direct experience in the field.
Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks.
May lead and direct the work of others.
A wide degree of creativity and latitude is expected.
Typically reports to a manager or head of a unit/department.
Provide support for the regulatory department to ensure efficient and compliant business processes and environment.
The individual may execute tasks and exercise influence generally at the middle management level.
The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.
Top 5 skills/requirements HM would like to see on a resume -
About Us
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
Visit us at https://divihn.com/find-a-job/ to learn more and view our open positions.
Please apply or call one of us to learn more
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Meghna at (224) 369-4230
Rashi at (630) 847-1027
Title: Regulatory Affairs Associate
Location: Abbott Park, IL
Duration: 9 Months
Description
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
Review/approval of engineering study protocols/reports and validation study protocols/reports.
Review and approval of manufacturing changes for Class III implantable medical devices.
May require an advanced degree and 5-8 years of direct experience in the field.
Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks.
May lead and direct the work of others.
A wide degree of creativity and latitude is expected.
Typically reports to a manager or head of a unit/department.
Provide support for the regulatory department to ensure efficient and compliant business processes and environment.
The individual may execute tasks and exercise influence generally at the middle management level.
The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.
Top 5 skills/requirements HM would like to see on a resume -
- Quick learner and team player
- Effective written and oral communication skills
- Critical and Analytical thinking skills.
- Attention to details
- Basic Technical knowledge on diagnostics and exposure to Regulatory documentation is preferable.
- Multitasking , be able to work in fast paced environment to meet dead lines and project management skills is an asset.
About Us
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
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Seniority level
Associate -
Employment type
Temporary -
Job function
Legal -
Industries
Software Development
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