SEKISUI Diagnostics, LLC
Manager, Regulatory Affairs
SEKISUI Diagnostics, LLC, San Diego, California, United States, 92189
At SEKISUI Diagnostics, a leader in invitro diagnostics, we help improve patient outcomes by focusing on innovating and developing highly accurate diagnostics tests, reagents, and systems. We are seeking a highly motivated leader within the Molecular Diagnostics space to lead a team of talented scientists and engineers in the development of devices to improve healthcare.
About you:
You are a seasoned professional in the Regulatory Affairs space with specific experience with IVD and POC products. You have experience in the past with US regulatory affairs submissions such as 510(k) and/or PMA. You have at least 10 years of experience in this field so far in your career.
To be successful in this role you will:
Have previous experience with various regulatory affairs submissions.
Understand how to take the lead with submissions, and you are an expert when it comes to preparing 510(k) and other regulatory registrations.
About us:
At SEKISUI Diagnostics, we help improve patient outcomes by focusing on innovating and developing highly accurate diagnostics tests, reagents, and systems. Our global capabilities allow us to meet the specific needs of our wide range of customers and customize solutions at both a regional and product level.
SEKISUI offers a competitive compensation and benefits package.
Equal Opportunities:
As an equal opportunity employer, SEKISUI Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other prohibited grounds specified in applicable country and local laws.
SEKISUI Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the Company’s internal recruiting team.
The anticipated base compensation for this position is $120,000 – $140,000. This role may also qualify for annual incentives and/or comprehensive benefits.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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About you:
You are a seasoned professional in the Regulatory Affairs space with specific experience with IVD and POC products. You have experience in the past with US regulatory affairs submissions such as 510(k) and/or PMA. You have at least 10 years of experience in this field so far in your career.
To be successful in this role you will:
Have previous experience with various regulatory affairs submissions.
Understand how to take the lead with submissions, and you are an expert when it comes to preparing 510(k) and other regulatory registrations.
About us:
At SEKISUI Diagnostics, we help improve patient outcomes by focusing on innovating and developing highly accurate diagnostics tests, reagents, and systems. Our global capabilities allow us to meet the specific needs of our wide range of customers and customize solutions at both a regional and product level.
SEKISUI offers a competitive compensation and benefits package.
Equal Opportunities:
As an equal opportunity employer, SEKISUI Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other prohibited grounds specified in applicable country and local laws.
SEKISUI Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the Company’s internal recruiting team.
The anticipated base compensation for this position is $120,000 – $140,000. This role may also qualify for annual incentives and/or comprehensive benefits.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
#J-18808-Ljbffr