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Regulatory Affairs Manager Remote
Quidel San Diego, CA
$123k-163k (estimate)
Full Time 7 Months Ago
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Quidel is Hiring a Remote Regulatory Affairs Manager Remote

Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. We are a leading manufacturer of point of care diagnostic solutions. Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. We are excited to announce that Quidel Corporation is now becoming QuidelOrtho! This transaction will bring together two world-class teams and complementary product portfolios to serve patients around the world. During this transition period, we encourage you to continue visiting our career site and also check out more career opportunities at Careers at Ortho Clinical Diagnostics | Ortho Clinical Diagnostics jobs Join our journey as we become one global diagnostics leader!We are looking for a remote Regulatory Affairs Manager to join our Regulatory Affairs team. The Regulatory Affairs Manager implements regulatory activities related to the approval of new IVDs (in vitro diagnostics) and medical devices into the worldwide market, as directed. Participates on product development teams and provides guidance and strategies for regulatory issues. Interacts with regulatory agencies regarding product registrations, licensures and permits, and supports regulatory compliance to QSR, ISO, CMDR, MDSAP, IVDD/IVDR, CFR and other worldwide regulatory requirements. Reviews and approves labeling and Marketing/Sales literature.This position operates from roughly 8:00 am - 5:00 pm Pacific Standard Time, Monday - Friday. #LI-AP1#LI-RemoteBefore you apply, please make sure you share Quidel’ s values. We pride ourselves on keeping these values in mind every day as we execute on goals and plan for the future. We are seeking employees who share the same mindset and commitment to be customer driven, focused on execution, and new product oriented. We succeed by being determined, optimistic team players. Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Job Summary

JOB TYPE

Full Time

SALARY

$123k-163k (estimate)

POST DATE

08/04/2022

EXPIRATION DATE

12/22/2022

WEBSITE

quidel.com

HEADQUARTERS

ATHENS, OH

SIZE

1,000 - 3,000

FOUNDED

1979

TYPE

Public

REVENUE

$1B - $3B

INDUSTRY

Pharmaceutical

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About Quidel

Quidel is a diagnostic product manufacturer that produces and supplies rapid test kits and cellular-based virology assays for the healthcare sector.

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The job skills required for Regulatory Affairs Manager Remote include Regulatory Affairs, Product Development, Regulatory Compliance, ISO, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs Manager Remote. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Affairs Manager Remote. Select any job title you are interested in and start to search job requirements.

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The following is the career advancement route for Regulatory Affairs Manager Remote positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Manager Remote, it can be promoted into senior positions as a Regulatory Affairs Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Manager Remote. You can explore the career advancement for a Regulatory Affairs Manager Remote below and select your interested title to get hiring information.

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If you are interested in becoming a Regulatory Affairs Manager, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Regulatory Affairs Manager for your reference.

Step 1: Understand the job description and responsibilities of an Accountant.

Quotes from people on Regulatory Affairs Manager job description and responsibilities

Regulatory Affairs Managers plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

04/15/2022: Charleston, SC

They will provide responses to regulatory agencies regarding product information or issues.

04/10/2022: Charleston, SC

They'll establish regulatory priorities or budgets and allocate resources and workloads.

02/22/2022: Temple, TX

Ensures sponsored studies are disclosed according to applicable laws, regulatory requirements and policies.

02/15/2022: Harlingen, TX

The position will provide regulatory review, registration and data management, strategic regulatory advice and submissions to appropriate regulatory agencies.

05/09/2022: New Brunswick, NJ

Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.

Career tips from people on Regulatory Affairs Manager jobs

Having the knowledge and understanding of complex medical and scientific subject matter would give you advantage for this role.

03/10/2022: Springfield, OR

You need the ability to build networks to obtain cooperation.

03/12/2022: Temple, TX

Manager Regulatory Affairs are able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.

04/10/2022: Great Falls, MT

They utilize their technical skills to ensure products remain safe and efficient by meeting all the regulatory standards.

03/28/2022: Lowell, MA

You need to have IT skills, particularly in relation to using databases and familiarity with commercial software to qualify for this role.

03/28/2022: Anchorage, AK

Step 3: View the best colleges and universities for Regulatory Affairs Manager.

Butler University
Carroll College
Providence College
Rollins College
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Amherst College
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