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VALID8 Financial

Associate Manager, Regulatory Affairs

VALID8 Financial, Leesburg, Virginia, United States, 22075

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Location: Leesburg, VA (hybrid) Company: VB Spine Looking for a career where your work truly matters? At VB Spine, youll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. Were seeking an Associate Manager, Regulatory Affairs to lead regulatory strategy and operations across the product lifecycle. In this role, youll mentor regulatory professionals, manage submissions, ensure compliance with FDA and international standards, and serve as a key interdepartmental resource shaping the future of VB Spine. What Youll Do:

Develop and drive domestic and international regulatory strategies for multiple sites Provide regulatory guidance to product development teams and leadership Prepare, submit, and manage applications with Health Authorities, including FDA submissions (510(k), IDEs, etc.) Serve as primary regulatory reviewer for labeling, advertising/promotion, change controls, and quality documentation Monitor and assess evolving regulatory requirements and implement compliant processes Mentor and lead a small team of Regulatory Affairs professionals Represent RA on cross-functional teams and lead site-specific regulatory integration activities Support corporate and divisional RA initiatives, including training programs and due diligence opportunities Evaluate regulatory risks and develop innovative compliance strategies aligned with business needs What You Bring:

B.A./B.S. in Science, Legal, Regulatory, or Engineering (Advanced Degree or RAC certification preferred) 7+ years of regulatory experience in medical device or pharmaceutical industries Strong analytical and strategic thinking skills with proven ability to manage multiple projects Demonstrated leadership and mentoring abilities Excellent written and verbal communication skills, with strong attention to detail Advanced PC skills and ability to work in regulated environments Knowledge of FDA and international regulatory frameworks, risk management, and submission processes Why VB Spine?

We believe in growing talent from within. At VB Spine, youll join a high-performing team, benefit from peer and executive mentorship, and influence strategy in the dynamic field of medical devicespositioning yourself to impact growth and innovation across the organization. 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 $145,000 - $165,000 annually, plus bonus potential and a comprehensive benefits package. 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 Apply for this job

First name Last name Email address Location Phone number Resume Attach resume Attach another file Attach file What are your hours of availability? monday tuesday wednesday thursday friday saturday sunday What is your Linkedin Profile URL? What is the name of your current employer? Are you authorized to work in the United States? Are you authorized to work in the United States? Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)? Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)? What is your personal website or portfolio URL? Do you have any professional qualifications (PMP, MCSE)? What is the highest level of education youve obtained? What is the highest level of education youve obtained? This role requires a HYBRID work schedule in which you need to be in the office 2-4 times a week depending on the needs of the business. Are you able to meet those requirements? Yes No How did you hear about this position? If you were referred, please list the name of the referring employee. Do you have a non-compete that could impact your ability to work for VB Spine? 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 Pac Island (Not Hispanic or Latino) White (Not Hispanic or Latino) Two or More Races (Not Hispanic or Latino) Decline to Specify If you believe you belong to any of the categories of protected veterans listed below, please indicate by selecting the appropriate category(ies). The hiring employer is subject to the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended by the Jobs for Veterans Act of 2002, 38 U.S.C. 4212 (VEVRAA) and requests this information in order to measure the effectiveness of the outreach and positive recruitment efforts it undertakes pursuant to VEVRAA. 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. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labors Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp. Yes, I Have A Disability, Or Have A History/Record Of Having A Disability No, I Dont Have A Disability, Or A History/Record Of Having A Disability I Dont Wish To Answer #J-18808-Ljbffr