Position: Regulatory Affairs Associate
The Regulatory Affairs Associate will provide the internal regulatory affairs support for post-marketing of Class I , II and III medical devices. The incumbent will support the registrations and technical files projects for existing and acquired product lines. At the direction of the Sr. Director of Regulatory Affairs & Compliance, the Regulatory Affairs Associate monitors the regulatory environment and provides assessments of the impact of new and changing regulations.
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 both domestic and international locations.
Assembles, Reviews and updates “Technical Files” for existing and acquired products.
Prepares and updates “Declarations of Conformity” as per MDD.
Processes and updates CFGs.
Supports International Standards Organization implementation and maintenance.
Reviews Medical Device Regulatory standards and updates to ensure compliance.
Notifies Supervision and Management of Product safety issues.
Assists with maintaining and updating Order Entry Restrictions database.
Provides liaison with FDA, Notified Body, and Authorized European Reps.
Maintains collaborative relationship with R & D, Marketing and Operations is required.
Maintains collaborative relationships with external partners including regulators and external OEM suppliers.
Performs additional duties as required by management.
Bachelor’s Degree in Sciences, Engineering, Technical or equivalent.
Minimum 3-5 years quality, regulatory, compliance manufacturing, operations and/or engineering is required
Command of Medical Device QSRs, ISO 13485, MDD 93/42/EEC, Canadian Regulations.
Three - Five years QA/RA experience in the medical device or related industry.
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.
As an employee of CooperSurgical, you’ll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a competitive salary, insurance coverage, 401(k) and a defined pension plan, paid time off for vacation, personal, sick and holidays, as well as a wide range of other perks and benefits. Please visit us at www.coopersurgical.com
to learn more about CooperSurgical and the benefits of becoming a member of our team.
CooperSurgical is an equal employment opportunity employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran
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