New

Senior Clinical Regulatory Affairs Specialist

Vaco
$110,000.00 - $130,000.00 / yr
401(k), retirement plan
United States, Tennessee, Memphis
Jul 20, 2025
Location: Memphis, TN (/On-site) Relocation Available Employment Type: Full-Time Department: Clinical & Regulatory Affairs About the Role We are seeking a dynamic and experienced Senior Clinical/Regulatory Affairs Specialist to lead clinical research initiatives and support regulatory strategies across U.S. and international markets. This critical role involves managing all phases of clinical investigations (including U.S. IDE studies), ensuring compliance with global regulatory standards, and working cross-functionally with R&D, Quality, Marketing, and Operations teams to bring innovative medical devices to market. Key Responsibilities Clinical Affairs - 60% Lead the design, planning, and execution of feasibility, pivotal, and post-market clinical studies. Develop clinical strategies to support FDA (IDE, 510(k), De Novo, PMA) and EU (MDR) submissions. Author and manage key clinical study documentation: protocols, CRFs, ICFs, investigator brochures, and study reports. Collaborate with PIs, CROs, and internal stakeholders to ensure studies are executed on time and in compliance with ISO 14155 and ICH GCP. Submit IDE applications and manage FDA communications including pre-submissions, deficiency responses, and annual reports. Review clinical data and prepare summaries, manuscripts, abstracts, and white papers. Engage KOLs to support clinical and scientific initiatives. Provide clinical review and input on training, marketing, and educational materials. Regulatory Affairs - 30% Support regulatory strategies for U.S. and EU markets for new and existing products. Prepare and submit regulatory documentation including technical files, FDA submissions, and Notified Body communications. Guide cross-functional teams on global regulatory requirements and product classification. Manage FDA Establishment Registration, device listings, and annual renewals. Investigate and document product complaints, support recalls or field actions as needed. Support audits, inspections, and regulatory reviews. Monitor regulatory landscape and ensure company-wide compliance. Coordinate with the company's Regulatory team in Ireland. Veterinary & Operations Support - 10% Provide regulatory support for veterinary medical devices and OTC topical products. Review product labeling, packaging, and marketing materials for regulatory accuracy. Assist with U.S. operations including vendor coordination, inventory management, and document control. Support cross-functional projects involving customer communications and supply chain. Qualifications Bachelor's, Master's, or Ph.D. in Life Sciences, Biomedical Engineering, or related field. Minimum of 5 years of clinical research experience in the medical device industry. Certification in clinical research (e.g., CCRP, CCRA) preferred. In-depth knowledge of FDA regulations, ISO 14155, ICH GCP, and EU MDR. Strong clinical data analysis and scientific writing skills. Proven ability to manage multiple studies in a fast-paced environment. Experience with EDC systems and clinical trial management software. Technical understanding of medical devices and physiological systems. Highly detail-oriented, organized, and results-driven. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual's skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs. With that said, as required by local law in geographies that require salary range disclosure, Vaco/Highspring notes the salary range for the role is noted in this job posting. The individual may also be eligible for discretionary bonuses, and can participate in medical, dental, and vision benefits as well as the company's 401(k) retirement plan. 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.