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Senior Clinical Regulatory Affairs Specialist

Vaco
$100,000.00 - $140,000.00 / yr
401(k)
United States, Tennessee, Memphis
Jul 03, 2025
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Senior Clinical & Regulatory Affairs Specialist
? Memphis, TN | Hybrid On-Site | Medical Devices
? Full-Time | $95K-$140K + 6% 401(k) Match + 25 Days PTO + Platinum BCBS

Are you ready to own complex clinical trials and shape regulatory strategy for innovative medical devices?
We have a client that is a fast-growing, international medical device company preparing to launch U.S. and EU trials for novel biomaterial technologies - and we're adding a key Senior Clinical/Regulatory Affairs Specialist to their Memphis team.

? What You'll Do
  • Lead & deliver multiple clinical trials (IDE & PMCF) from study design to close-out.

  • Prepare & submit IDEs, 510(k)s, PMAs, and support EU MDR compliance.

  • Coordinate directly with FDA, Notified Bodies, CROs, PIs, and global partners.

  • Ensure site monitoring, study protocols, risk analysis, and compliance align with ISO 14155 and ICH GCP.

  • Support post-market surveillance and product development strategies.

  • Collaborate cross-functionally with Regulatory, R&D, Quality, and Operations.

  • Some support for veterinary devices and OTC products.

? What You Bring
  • 5+ years of experience in clinical research for medical devices (IDE experience strongly preferred).

  • Hands-on expertise with FDA submissions & regulatory strategy.

  • Solid grasp of ISO 14155, GCP, EU MDR.

  • Experience with EDC systems (RedCap, Medidata, Veeva, or similar).

  • Strong ability to independently drive trials with minimal supervision.

  • Bachelor's or higher in Life Sciences, Biomedical Engineering, or related field.

  • Willingness to travel ~20-25% (Ireland, NY site).

Vaco by Highspring values a diverse workplace and strongly encourages women, people of color, LGBTQ+ individuals, people with disabilities, members of ethnic minorities, foreign-born residents, and veterans to apply.

EEO Notice

Vaco by Highspring is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race (including but not limited to traits historically associated with race such as hair texture and hair style), color, sex (includes pregnancy or related conditions), religion or creed, national origin, citizenship, age, disability, status as a veteran, union membership, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, political affiliation, or any other protected characteristics as required by federal, state or local law.

Vaco by Highspring and its parents, affiliates, and subsidiaries are committed to the full inclusion of all qualified individuals. As part of this commitment, Vaco by Highspring and its parents, affiliates, and subsidiaries will ensure that persons with disabilities are provided reasonable accommodations. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact HR@vaco.com .

Vaco by Highspring also wants all applicants to know their rights that workplace discrimination is illegal.

By submitting to this position, you agree that you will be giving Vaco by Highspring the exclusive right to present your as a candidate for the foregoing employment opportunity. You further agree that you have represented information about yourself accurately and have not affirmatively misrepresented your qualifications. You also agree to maintain as confidential, to the fullest extent permitted by law, any information you learn from Vaco by Highspring about the position and you will limit disclosure of information about the position only to the extent necessary to perform any obligations in furtherance of your application. In exchange, Vaco by Highspring agrees to exercise reasonable efforts to represent you through all solicitation, job screening and resume dispersal.

Privacy Notice

Vaco by Highspring and its parents, affiliates, and subsidiaries ("we," "our," or "Vaco by Highspring") respects your privacy and are committed to providing transparent notice of our policies.

  • California residents may access Vaco by Highspring HR Notice at Collection for California Applicants and Employees here.
  • Virginia residents may access our state specific policies here.
  • Residents of all other states may access our policies here.
  • Canadian residents may access our policies in English here and in French here.
  • Residents of countries governed by GDPR may access our policies here.
Pay Transparency Notice

Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to:

  • the individual's skill sets, experience and training;
  • licensure and certification requirements;
  • office location and other geographic considerations;
  • other business and organizational needs.

With that said, as required by local law, Vaco by Highspring believes that the following salary range referenced above reasonably estimates the base compensation for an individual hired into this position in geographies that require salary range disclosure. The individual may also be eligible for discretionary bonuses.

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