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Regulatory Specialist

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POST DATE 10/11/2017
END DATE 3/24/2018

Braemar Biotelemetry Technology San Diego, CA

Location
San Diego, CA
AJE Ref #
579727255
Job Classification
Full Time
Job Type
Regular
Company Ref #
2017-2716
Experience
Mid-Career (2 - 15 years)
Education
Bachelors Degree

JOB DESCRIPTION

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REGULATORY SPECIALIST

Location US-CA-San Diego
Posted Date 5 months ago(10/10/2017 3:42 PM)

Job ID

2017-2716

# Positions

1

Experience (Years)

5

Category

Research and Development

Company

Braemar Biotelemetry Technology

OVERVIEW

Regulatory Specialist

RESPONSIBILITIES

Responsibilities:

* Support/organize/write regulatory submission for new products and product changes as required ensuring timely approval for market release and in accordance with applicable regulations, standards and guidance.

* In collaboration with Regulatory management, support submission activities for devices in gaining required clearances through the processes of IDE's, 510(k)s, PMA's, CE marking.

* Maintain current knowledge of the development and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals within the company and sector.

* Maintain documentation and logs related to regulatory registrations and submissions

* Generate/support the creation of technical files, essential requirements and declaration of conformity.

* Support the development and implementation of the regulatory department's policies and procedures and strategic objectives.

* Support/draft regulatory strategy document for new product launch

* Participate as the regulatory representative on project teams and new product launches to provide guidance and direction on regulatory requirements. Complete regulatory evaluation of device changes as needed. Review and approve documentation related to product launches.

* As needed, work with Authorized European Representative to provide required documentation for registration.

* Provide guidance and review of product labeling, promotional material, change control and other related product documentation as needed.

* Assist with internal audits and audits from external regulatory bodies.

* Support maintenance of the company's Medical Device Listing and Device Establishment registration forms.

* Recommend modification to internal guidelines, work instructions, and procedures. Draft Regulatory procedures and support updates to other Quality System procedures as needed.

* Support cross functional sites (San Diego, Eagan, Rosemont) with regulatory needs

* Support and may lead regulatory projects as needed

* The position reports directly to Regulatory Manager

QUALIFICATIONS

Qualifications:

* Excellent communication skills, ability to communicate and work at all levels of the organization.

* Strong technical writing skills

* Excellent general IT skills; i.e. Microsoft Office/Outlook, etc.

* Strong organizational skills and high attention to detail. Ability to deal with high stress situations is a must.

* Strong knowledge and application of 21 CFR 820, ISO 13485

* Bachelor's degree in Science or Engineering

* 5 years previous experience in Regulatory/Quality in the medical device field

* Ability to work in a flexible, dynamic work environment





BioTelemetry is an Equal Opportunity Employer

COMPANY

Braemar Biotelemetry Technology

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