CooperSurgical · 1 day ago

Remote - Regulatory Affairs Associate

Trumbull, CT

Full-time

Remote

Entry Level

$70K/yr - $95K/yr

2+ years exp

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Responsibilities

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.

Qualification

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Regulatory ComplianceMedical Device RegulationsISO 9001Project Organizational SkillsAdvanced Computer SkillsDegree in Sciences

Required

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 problem-solving 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.