Regulatory Analyst III

Position Objective:

Provides Regulatory Affairs and Regulatory Compliance guidance and support to Life Technologies in support of its IVD products in respect to regulatory compliance matters to assist the Company in achieving its business goals and pursuing opportunities while ensuring compliance with various governmental regulations. Assist customers by providing regulatory guidance and support as it applies to the use of our products and services. This position will have direct line reporting to: Sr. Regulatory Affairs Manager.

Essential Functions:

As the regulatory expert, the incumbent is required to provide leadership and training to assure that all regulatory submissions and compliance matters are planned, communicated and executed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations as well as coordinate issue resolution through the use of outside consultants, regulatory agencies, and / or internal resources. Requires the ability to provide solutions based on their own knowledge and industry experience base. Some travel is required.

Prepare U.S. 510(k) regulatory submissions, preparation/maintenance of Technical Files for European CE-IVD products, preparation/renewal of CMDL for Canada. Prepare regulatory submissions for health authorities in other countries. Prepare and maintain state and federal medical device licensing, establishment registration and listings, MDR reporting. Obtain regulatory permits, including compliance with import / export clearance requirements and regulations. Regulatory assessment of new and changed products. Labeling / marketing material review. Participate in Project Teams and New Product Introduction Teams.

Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc. Conduct training and/or communicate appropriate material to internal staff to aid in compliance.

Develops regulatory affairs internal policies and procedures, and provide compliance training.

Responsible to provide regulatory guidance to the site via training, review of protocols, validations, and SOPs. Participate in QMR meetings and post-marketing surveillance

Responsible for preparing and submitting Medical Device and Vigilance Reports. Prepares procedures and processes to support reporting strategy.

Host FDA and other regulatory authority inspections and participate in ISO and customer audits as needed.

Ensure compliance with all U.S. and international regulatory requirements pertaining to product approval, marketing, and labeling.

May perform audits, both physical and paper, to ensure compliance with various regulations. May coordinate audit through outside vendor.

Educational Requirements:

A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science. M.S. or M.B.A. is a plus.

Experience Requirements:

  • Must have a minimum of 5 years of Regulatory Affairs In-Vitro Diagnostic Medical Device technical work experience, or an equivalent combination of education and experience.Regulatory certification is a plus.
  • In-Vitro Diagnostic/Medical Device regulatory affairs:Regulations, Submissions (510(k), PMA, IDE), Technical Files (IVDD), CMDL, cGMP/Quality Systems, Regulatory Compliance and Import/Export regulations.

Direct and positive experience in communicating with Regulatory Authorities and Distributors.

Multi-site experience, in a mid to large size company.

Desired Profile:

High energy level; positive attitude; works well under stress

Strong communicator

Hands-on, action-oriented, and able to implement effectively through his/her team

Continuous improvement minded; used to balancing the need for Quality and the need for efficiency

Able to work autonomously in a matrix-managed organization

Willingness to travel (~10-20%)

Comfortable with ambiguity and change

Good business sense for what’s practical, and what’s not, what’s needed for what parts of the business. Good sense for Operations in general. Able to effectively operate in a cost-conscious environment.

Posted
10/04/2021
Type
Full time
Salary Range
$59,000.00 - 90,000.00
per Year
Salary range estimated by
Location
Austin, TX, US
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