Regulatory Affairs Specialist - REMOTE
Jobot
Atlanta Georgia
United States
Government
(No Timezone Provided)
This Jobot Job is hosted by: Hunter Prater
Are you a fit? Easy Apply now by clicking the "Apply on company site" button and sending us your resume.
A bit about us:
Our client is a growing medical device company with an exciting product for skin repair
Why join us?
Stock Options
401k with a Generous Match
Multiple Health Care Plans
Dental/Vision
Company-sponsored Short-Term Disability, Long-Term Disability and Life Insurance
Job Details
Primary Function
The Regulatory Affairs Specialist is a key contributor to the company's regulatory group focused on support for company's regenerative products. Additionally, the role includes participation in project development teams to provide early guidance, review, and approval of submission-related documentation.
Duties/Responsibilities
- RA lead for all activities associated with changes to the on-market product (supplier, design, manufacturing, etc.)
- Assesses changes for any regulatory action required in the US, EU, AU/NZ, and Japan
- Prepares FDA submissions (PMA supplements) to ensure timely approvals and market release for product changes
- Assists in MDR preparation activities
- Reviews and approves product testing and other submission related deliverables to ensure regulatory compliance
- Collaborates with the new product development team and provides regulatory support as required
- Reviews and Revises SOPs, and other company and departmental procedures to ensure quality system compliance
- Participates in device development design reviews and risk management activities
- Establishes and maintains relationships within the company's medical quality, R & D, and operations teams
Special Knowledge/Skills
- Experience in the development of FDA submissions for a medical device (IDE, 510 (k), HDE, PMA, or PMA supplements)
- Experience in reviewing and/or approving engineering reports/data or changes
- Ability to comprehend principles of engineering and/or medical device use
- Ability to process complex technical reports into understandable summaries
- Ability to effectively manage multiple projects and priorities
- Excellent written and oral communication skills with proficiency in Microsoft Word and PowerPoint
- Excellent technical writing skills and attention to detail
- Ability to work independently and as a member of a team
- Capable of managing multiple projects simultaneously
Experience
- 3+ yrs of professional work experience in regulatory affairs
- Experience in Class III medical device industry
Education/Training
- Degree in engineering or physical/biological sciences
- Regulatory Affairs Certification (RAC) preferred
Travel Expectations
- Able to travel up to 10% of the time
Position Location
- US
Interested in hearing more? Easy Apply now by clicking the "Apply on company site" button.
Regulatory Affairs Specialist - REMOTE
Jobot
Atlanta Georgia
United States
Government
(No Timezone Provided)
This Jobot Job is hosted by: Hunter Prater
Are you a fit? Easy Apply now by clicking the "Apply on company site" button and sending us your resume.
A bit about us:
Our client is a growing medical device company with an exciting product for skin repair
Why join us?
Stock Options
401k with a Generous Match
Multiple Health Care Plans
Dental/Vision
Company-sponsored Short-Term Disability, Long-Term Disability and Life Insurance
Job Details
Primary Function
The Regulatory Affairs Specialist is a key contributor to the company's regulatory group focused on support for company's regenerative products. Additionally, the role includes participation in project development teams to provide early guidance, review, and approval of submission-related documentation.
Duties/Responsibilities
- RA lead for all activities associated with changes to the on-market product (supplier, design, manufacturing, etc.)
- Assesses changes for any regulatory action required in the US, EU, AU/NZ, and Japan
- Prepares FDA submissions (PMA supplements) to ensure timely approvals and market release for product changes
- Assists in MDR preparation activities
- Reviews and approves product testing and other submission related deliverables to ensure regulatory compliance
- Collaborates with the new product development team and provides regulatory support as required
- Reviews and Revises SOPs, and other company and departmental procedures to ensure quality system compliance
- Participates in device development design reviews and risk management activities
- Establishes and maintains relationships within the company's medical quality, R & D, and operations teams
Special Knowledge/Skills
- Experience in the development of FDA submissions for a medical device (IDE, 510 (k), HDE, PMA, or PMA supplements)
- Experience in reviewing and/or approving engineering reports/data or changes
- Ability to comprehend principles of engineering and/or medical device use
- Ability to process complex technical reports into understandable summaries
- Ability to effectively manage multiple projects and priorities
- Excellent written and oral communication skills with proficiency in Microsoft Word and PowerPoint
- Excellent technical writing skills and attention to detail
- Ability to work independently and as a member of a team
- Capable of managing multiple projects simultaneously
Experience
- 3+ yrs of professional work experience in regulatory affairs
- Experience in Class III medical device industry
Education/Training
- Degree in engineering or physical/biological sciences
- Regulatory Affairs Certification (RAC) preferred
Travel Expectations
- Able to travel up to 10% of the time
Position Location
- US
Interested in hearing more? Easy Apply now by clicking the "Apply on company site" button.