Remote - Regulatory Affairs Associate - Trumbull, United States - The Cooper Companies

The Cooper Companies

Verified Company

Trumbull, United States

1 day ago

Posted by:

Mark Lane

beBee recruiter

Description

About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.

CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families.

We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

Bachelor's degree in Sciences, Engineering, Technical or equivalent.
2 years experience in Regulatory and/or Compliance in related industry.
Working knowledge of Medical Device FDA QSRs, Reproductive Tissue Regulations, Stem Cell Regulations, ISO 9001, Rest of World Regulations (i.e. EU IVDR Canadian Regulations).
Strong communication and problemsolving skills.
Advanced computer skills.
Project organizational skills.
Passing of background check, which may include verification of prior employment, criminal conviction history, educational and driving records.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status.

We are proud to be an equal opportunity workplace.

Identifies, completes, and files all necessary documentation as required with applicable Regulatory bodies, both domestic and international for product registrations.
Identifies, completes, and files all necessary documentation as required for site registrations for both domestic and international locations.
Reviews Regulatory standards and updates to ensure compliance.
Collaborates with the Global RA team to maintain the regulatory databases through updating product data and registration data.
Utilizes the FDA FURLS database to renew annual site establishment listings and obtain device listing data for registrations.
Processes and updates CFGs through the FDA FURLS database.
Drafts and updates work instructions relative to the Regulatory Affairs department.
Notifies Leadership of any regulatory challenges.
Maintains collaborative relationship with cross functional stake holders, external partners including regulators, and external suppliers.
Performs additional duties as required by management.

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