Valid8 Financial, Inc.
Senior Regulatory Affairs Specialist
Valid8 Financial, Inc., Leesburg, Virginia, United States, 22075
Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission‑focused team that supports surgeons during life‑changing spinal procedures. We’re seeking a Senior Regulatory Affairs Specialist to plan, organize, and implement strategies that secure global regulatory approvals for innovative spinal medical devices and combination products. In this role, you’ll partner with cross‑functional teams, support submissions to FDA and international authorities, and ensure compliance across the product lifecycle—all while providing leadership and guidance to junior Regulatory Affairs colleagues.
What You’ll Do:
Develop and implement regulatory strategies for new and revised product lines
Prepare, author, and submit regulatory documents (e.g., 510(k), IDE, PMA, CE Technical Files, Design Dossiers)
Lead U.S. and EU market approval processes and ensure compliance with regulatory standards
Support post‑market submissions (progress reports, annual reports, etc.)
Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers
Communicate and negotiate with FDA and international regulatory authorities
Review and approve labeling, IFUs, and promotional materials
Establish and maintain regulatory information systems
Interpret new or existing regulations and ensure business practices align with compliance requirements
Mentor and provide guidance to Regulatory Affairs Specialists/Associates
Contribute to continuous improvement initiatives and process optimization within RA
What You Bring:
Bachelor’s degree in a scientific area (RAC certification preferred)
3+ years of experience in a regulated FDA environment (medical devices or combination products)
Hands‑on experience with 510(k) submissions (IDE and PMA knowledge a plus)
Strong understanding of FDA and EU medical device regulations (international experience desirable)
Direct experience interacting with FDA reviewers/inspectors
Strong organizational, communication, and planning skills with proven ability to lead team initiatives
Proficiency with PC systems and office applications
Solid understanding of scientific principles applied to regulatory affairs
Why VB Spine? We believe in growing talent from within. At VB Spine, you’ll join a high‑performing team, benefit from peer and executive mentorship, and gain opportunities to shape strategy in the dynamic medical device industry—positioning yourself to make a meaningful impact on growth and innovation.
Compensation: Pay for this role is competitive and based on experience, with additional factors like qualifications and performance taken into account. The typical pay range for this position is $100,000 - $110,000 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case‑by‑case basis and considers experience level, skillset, and market conditions.
Benefits include:
Comprehensive health, dental, and vision insurance
401(k) with company match
Paid time off (PTO) and holidays
Ongoing training and professional development opportunities
Opportunity to grow within a fast‑paced, mission‑driven company
Equal Opportunity & Diversity We invite you to complete the optional self‑identification questions below used for compliance with government regulations and record‑keeping guidelines. Any self‑identification information provided will not be considered in the selection process.
GENDER: Male Female Nonbinary I do not wish to self‑identify my gender
ETHNICITY: American Indian/Alaska Native (Not Hispanic or Latino); Asian (Not Hispanic or Latino); Black/African American (Not Hispanic or Latino); Hispanic/Latino; Native Hawaiian/Other Pacific Islander (Not Hispanic or Latino); White (Not Hispanic or Latino); Two or More Races (Not Hispanic or Latino); Decline to Specify
Veteran Status: Disabled Veteran, Armed Forces Service Medal Veteran, Veteran who served on active duty during a war or in a campaign or expedition for which a campaign badge has been authorized, Recently Separated Veteran, Veteran, but not one of the four protected classes above, I decline to state my veteran status, Not a Veteran
We are required by law to provide equal employment opportunity to qualified people with disabilities. ... (disability statement continues)
Yes, I Have A Disability, Or Have A History/Record Of Having A Disability; No, I Don’t Have A Disability, Or A History/Record Of Having A Disability; I Don’t Wish To Answer
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What You’ll Do:
Develop and implement regulatory strategies for new and revised product lines
Prepare, author, and submit regulatory documents (e.g., 510(k), IDE, PMA, CE Technical Files, Design Dossiers)
Lead U.S. and EU market approval processes and ensure compliance with regulatory standards
Support post‑market submissions (progress reports, annual reports, etc.)
Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers
Communicate and negotiate with FDA and international regulatory authorities
Review and approve labeling, IFUs, and promotional materials
Establish and maintain regulatory information systems
Interpret new or existing regulations and ensure business practices align with compliance requirements
Mentor and provide guidance to Regulatory Affairs Specialists/Associates
Contribute to continuous improvement initiatives and process optimization within RA
What You Bring:
Bachelor’s degree in a scientific area (RAC certification preferred)
3+ years of experience in a regulated FDA environment (medical devices or combination products)
Hands‑on experience with 510(k) submissions (IDE and PMA knowledge a plus)
Strong understanding of FDA and EU medical device regulations (international experience desirable)
Direct experience interacting with FDA reviewers/inspectors
Strong organizational, communication, and planning skills with proven ability to lead team initiatives
Proficiency with PC systems and office applications
Solid understanding of scientific principles applied to regulatory affairs
Why VB Spine? We believe in growing talent from within. At VB Spine, you’ll join a high‑performing team, benefit from peer and executive mentorship, and gain opportunities to shape strategy in the dynamic medical device industry—positioning yourself to make a meaningful impact on growth and innovation.
Compensation: Pay for this role is competitive and based on experience, with additional factors like qualifications and performance taken into account. The typical pay range for this position is $100,000 - $110,000 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case‑by‑case basis and considers experience level, skillset, and market conditions.
Benefits include:
Comprehensive health, dental, and vision insurance
401(k) with company match
Paid time off (PTO) and holidays
Ongoing training and professional development opportunities
Opportunity to grow within a fast‑paced, mission‑driven company
Equal Opportunity & Diversity We invite you to complete the optional self‑identification questions below used for compliance with government regulations and record‑keeping guidelines. Any self‑identification information provided will not be considered in the selection process.
GENDER: Male Female Nonbinary I do not wish to self‑identify my gender
ETHNICITY: American Indian/Alaska Native (Not Hispanic or Latino); Asian (Not Hispanic or Latino); Black/African American (Not Hispanic or Latino); Hispanic/Latino; Native Hawaiian/Other Pacific Islander (Not Hispanic or Latino); White (Not Hispanic or Latino); Two or More Races (Not Hispanic or Latino); Decline to Specify
Veteran Status: Disabled Veteran, Armed Forces Service Medal Veteran, Veteran who served on active duty during a war or in a campaign or expedition for which a campaign badge has been authorized, Recently Separated Veteran, Veteran, but not one of the four protected classes above, I decline to state my veteran status, Not a Veteran
We are required by law to provide equal employment opportunity to qualified people with disabilities. ... (disability statement continues)
Yes, I Have A Disability, Or Have A History/Record Of Having A Disability; No, I Don’t Have A Disability, Or A History/Record Of Having A Disability; I Don’t Wish To Answer
#J-18808-Ljbffr