Regulatory Affairs Specialist
PDS Tech Commercial, Inc. is seeking candidates for a Regulatory Affairs Specialist in Redmond, Washington .
Job Title:
Regulatory Affairs Specialist
Job Type:
Full time; Consultant (6 months)
Location:
Redmond, WA 98052
Schedule:
Monday to Friday; 8:
00 AM to 4:
30 PM
Pay Rate:
$58.00-$65.00 per hour
Job Description
The Regulatory Affairs Specialist is required to support product registrations in international markets. Requesting documentation from the FDA as well as legalizing USA documentation, e.g., the Apostille process, for international markets. Establishing a reliable method to ensure timely international market registration. Performs labeling reviews to ensure conformance to regulatory requirements. Additional regulatory and quality management system duties may be assigned.
Job
Responsibilities:
Fulfill open international product registration regulatory documentation requests
Establish an international product registration regulatory plan
Establish a reliable method to identify country-specific documentation and how to accomplish requirements like document authentication, e.g., the Apostille process
Establish a method so the sales and distribution teams know what countries are approved for distribution
Request FDA Certificates to Foreign Governments
Facilitate the legalization of the USA documentation process, e.g., the Apostille process to ensure international product registrations
Provide regulatory documentation to the shipping team for international product distribution
Reviews promotional and advertising labeling material and provides regulatory direction for communications to the sales force and training department relating to marketed products
Create and update technical documents, clinical evaluation reports, post-market clinical follow-up, and periodic safety update reports following adverse event reportability requirements.
Stay informed of new and pending requirements by researching regulatory requirements germane to the company
Other quality assurance and regulatory affairs assignments and projects as directed
Position
Qualifications:
Bachelor s degree required (life science or engineering preferred)
Minimum five years of regulatory experience with FDA and international product registration regulations and a strong knowledge of the medical device industry
FDA 510(k) and technical file submission experience preferred.
Extensive experience with the legalization of the USA documentation process, e.g., the Apostille process to ensure international product registrations
RAPS RAC or ASQ (CQA/CQM/CQE) or other certification preferred
Regulatory project management experience preferred
Strong communication, team building, written and verbal communication skills, and interpersonal & problem-solving skills
Ability to exercise sound judgment in prioritizing workflow
Ability to establish sound working relationships with different types of people with differing levels of skill and background is essential
Detail & deadline-oriented, well organized; demonstrated ability to organize, plan, and schedule tasks and communicate the status of projects on time
Pay Details:
$58.00 to $65.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https:
//www.pdstech.com/candidate-privacy
/>
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
Estimated Salary: $20 to $28 per hour based on qualifications.
Job Title:
Regulatory Affairs Specialist
Job Type:
Full time; Consultant (6 months)
Location:
Redmond, WA 98052
Schedule:
Monday to Friday; 8:
00 AM to 4:
30 PM
Pay Rate:
$58.00-$65.00 per hour
Job Description
The Regulatory Affairs Specialist is required to support product registrations in international markets. Requesting documentation from the FDA as well as legalizing USA documentation, e.g., the Apostille process, for international markets. Establishing a reliable method to ensure timely international market registration. Performs labeling reviews to ensure conformance to regulatory requirements. Additional regulatory and quality management system duties may be assigned.
Job
Responsibilities:
Fulfill open international product registration regulatory documentation requests
Establish an international product registration regulatory plan
Establish a reliable method to identify country-specific documentation and how to accomplish requirements like document authentication, e.g., the Apostille process
Establish a method so the sales and distribution teams know what countries are approved for distribution
Request FDA Certificates to Foreign Governments
Facilitate the legalization of the USA documentation process, e.g., the Apostille process to ensure international product registrations
Provide regulatory documentation to the shipping team for international product distribution
Reviews promotional and advertising labeling material and provides regulatory direction for communications to the sales force and training department relating to marketed products
Create and update technical documents, clinical evaluation reports, post-market clinical follow-up, and periodic safety update reports following adverse event reportability requirements.
Stay informed of new and pending requirements by researching regulatory requirements germane to the company
Other quality assurance and regulatory affairs assignments and projects as directed
Position
Qualifications:
Bachelor s degree required (life science or engineering preferred)
Minimum five years of regulatory experience with FDA and international product registration regulations and a strong knowledge of the medical device industry
FDA 510(k) and technical file submission experience preferred.
Extensive experience with the legalization of the USA documentation process, e.g., the Apostille process to ensure international product registrations
RAPS RAC or ASQ (CQA/CQM/CQE) or other certification preferred
Regulatory project management experience preferred
Strong communication, team building, written and verbal communication skills, and interpersonal & problem-solving skills
Ability to exercise sound judgment in prioritizing workflow
Ability to establish sound working relationships with different types of people with differing levels of skill and background is essential
Detail & deadline-oriented, well organized; demonstrated ability to organize, plan, and schedule tasks and communicate the status of projects on time
Pay Details:
$58.00 to $65.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https:
//www.pdstech.com/candidate-privacy
/>
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
Estimated Salary: $20 to $28 per hour based on qualifications.
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