Senior Regulatory Specialist - IVD
Senior Regulatory Specialist - IVD
Posted on :
20-01-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
20-01-2025
Job Description
Job Title: Senior Regulatory Specialist (m/f/d) IVD
Job Location: Wilmington DE USA
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: Associate
Job Description
Agilent encourages and supports discoveries that advance the quality of life. We provide life science diagnostic and applied market laboratories worldwide with instruments services consumables applications and expertise. Agilent enables customers to gain the answers and insights they seek so they can do what they do best: improve the world around us. Want more information on Agilent Check out !
We are searching for a highly motivated Senior Regulatory Specialist (m/f/d) to be part of our Global Regulatory Affairs team where you will play a key role in supporting new product introduction projects and developing regulatory strategies to help bring products to the global market coordinating and tracking international submissions product change notifications product release and licensing requirements and registration of IVD products for Agilent’s Biomolecular Analysis Division.
General Job Description:
As a member of the Agilent Regulatory Affairs organization and reporting to the Manager of Regulatory Affairs for Biomolecular Analysis this individual would develop and implement programs and processes to ensure that company products are safe meet customer needs and aligned with regional national and global regulations.
Preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies. Compiles materials required in submissions license renewal and annual registrations and maintains updated information about regional national and global regulatory requirements. Proactively manages the changing regulatory environment for company products prevents barriers to trade eliminates duplication of effort and identifies and mitigates areas of risk.
Reviews product labeling and marketing materials for accuracy and compliance with regulations. Responds to authorities’ requests/inquiries and/or internal partners dealing with regulations and product compliance.
Represents company through exchanges with external bodies dealing with standards and/or product regulations at the national/regional/global level.
May assess requirements and identify strategies for earliest possible approvals of clinical trials applications.
Key Role Responsibilities:
Qualifications
This job has a full time weekly schedule. It includes the option to work remotely.
Our pay ranges are determined by role level and location. Within the range individual pay is determined by work location and additional factors including jobrelated skills experience and relevant education or training. During the hiring process a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at:
Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other protected categories under all applicable laws.
Travel Required:
Occasional
Shift:
Day
Duration:
No End Date
Job Function:
Quality/Regulatory
Agilent encourages and supports discoveries that advance the quality of life. We provide life science diagnostic and applied market laboratories worldwide with instruments services consumables applications and expertise. Agilent enables customers to gain the answers and insights they seek so they can do what they do best: improve the world around us. Want more information on Agilent Check out !
We are searching for a highly motivated Senior Regulatory Specialist (m/f/d) to be part of our Global Regulatory Affairs team where you will play a key role in supporting new product introduction projects and developing regulatory strategies to help bring products to the global market coordinating and tracking international submissions product change notifications product release and licensing requirements and registration of IVD products for Agilent’s Biomolecular Analysis Division.
General Job Description:
As a member of the Agilent Regulatory Affairs organization and reporting to the Manager of Regulatory Affairs for Biomolecular Analysis this individual would develop and implement programs and processes to ensure that company products are safe meet customer needs and aligned with regional national and global regulations.
Preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies. Compiles materials required in submissions license renewal and annual registrations and maintains updated information about regional national and global regulatory requirements. Proactively manages the changing regulatory environment for company products prevents barriers to trade eliminates duplication of effort and identifies and mitigates areas of risk.
Reviews product labeling and marketing materials for accuracy and compliance with regulations. Responds to authorities’ requests/inquiries and/or internal partners dealing with regulations and product compliance.
Represents company through exchanges with external bodies dealing with standards and/or product regulations at the national/regional/global level.
May assess requirements and identify strategies for earliest possible approvals of clinical trials applications.
Key Role Responsibilities:
- Provide regulatory input and guidance on medical device Hardware and Software to various stakeholders
- Work collaboratively with crossfunctional teams across the intersecting business divisions to develop regulatory strategies to bring IVD and nonIVD product solutions to the global market. Ensure applicable regulatory requirements are incorporated into the product development life cycle
- Serve as the primary regulatory representative on new product introduction and new product or process improvement projects for instruments (including embedded software and firmware) and associated reagents / consumables used in NGS microarray qPCR and other bioanalysis applications providing regulatory guidance to crossfunctional teams and documenting regulatory strategy in accordance with applicable local and national regulatory requirements
- Responsible for creation and maintenance of Declaration of Conformity STED / technical file / design dossier GSPR checklist and other regulatory conformity assessment documents and records in accordance with applicable local and national regulatory requirements
- Provide regulatory review guidance input and approval on IFUs Safety User Manuals Labels CAPAs NCMRs Deviations Marketing and Promotional Content Materials and product changes
- Maintain UDI device registration information in applicable regulatory databases such as GUDID EUDMAED etc.
- Ensure compliance with applicable regulations and international standards for products throughout product life cycle
Qualifications
- Bachelor's or master's Degree in biological science or equivalent
- Proficient years of experience within a Regulatory Affairs function is highly preferred – but we are open for someone with a very solid understanding in medical device hardware and software who wants to transition into regulatory affairs
- Experience with IVD or hardware/software medical device systems
- Experience writing and submitting regulatory submissions is an advantage
- Experience working in ISO 13485 MDSAP IVDR or GMP environment supporting clinical markets is required
- Experience with RoHS (EU KSA UAE) EMC EU Battery Regulation or EU Machinery Regulation is preferred
- Competitive compensation and benefits package (yearly company bonus private health care pension scheme discounted stock purchase plan medical & life insurance…)
- Exciting projects in a dynamic collaborative team grounded on an agile culture
- Career development opportunities in an international company
- WorkLifeBalance is encouraged
- Permanent contract in a fastgrowing global company
This job has a full time weekly schedule. It includes the option to work remotely.
Our pay ranges are determined by role level and location. Within the range individual pay is determined by work location and additional factors including jobrelated skills experience and relevant education or training. During the hiring process a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at:
Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other protected categories under all applicable laws.
Travel Required:
Occasional
Shift:
Day
Duration:
No End Date
Job Function:
Quality/Regulatory
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Employment Type
Full Time
Key Skills
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