New · posted Nov 4
Saluda Medical Pty · Medical Devices
Manager, Clinical Affairs
- Minneapolis, MN
- On-site
- Full-time
- Manager
The role
Saluda Medical is a commercial‑stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed‑loop neuromodulation platform. The company’s proprietary technology senses and measures neural responses to stimulation and automatically adjusts therapy based on real‑time neurophysiological feedback.
Saluda Medical’s first product, the Evoke® System, is designed to deliver known, consistent, and personalized spinal cord stimulation therapy by objectively measuring neural responses and maintaining therapy within a prescribed therapeutic window. Saluda Medical is headquartered in Minneapolis, Minnesota.
At Saluda, we challenge boundaries. We innovate and think beyond the conventional. Our focus is to revolutionize the standard of care in neuromodulation to positively impact patient’s lives.
In this exciting role as a Manager, Clinical Affairs, you will be at the center of Saluda’s clinical study program. Your insights will contribute to formulating the clinical research and evidence generation strategy, and you will be responsible for the planning, implementation, managing, and reporting of the applicable clinical studies and associated regulatory activities in accordance with that strategy. To achieve this you will collaborate with a cross-functional team, including Research and Development, Marketing, Clinical Operations, Medical Affairs, Regulatory Affairs, Quality and Operations, enabling global market access and adoption of a new class III implantable electrical stimulation therapy worldwide. While driving program execution to meet customer needs and financial goals of the business, you will create and uphold a high-performance culture centered on customer focus, creative and determined problem solving, transparency and partnership.
What you need
Knowledge/Skills/Abilities
- Excellent verbal and written communication· Knowledge of ICH/GCP and FDA medical device regulations· Knowledge of research design, data analysis and biostatistics· Self-assured, knowledgeable professional capable of developing good interpersonal relationships with medical professionals· High degree of personal integrity
- Excellent organizational skills and attention to detail
- Self-motivated and independent work style with the ability to initiate and follow through on assignments
- Knowledge of electronic data capture systems and web-based clinical trial management tools
- Ability to think creatively, dynamically, and foster a culture of commitment to thoughtful science to help patients in need
Our Core Values:
- People – Our first responsibility is to the patients we serve.
- Integrity – Do the right thing
- Pioneering – Lead Boldly, Change Lives, Disrupt the Status-Quo
- Performance – Win together – Deliver with Excellence.
What you'll do
- Development, maintenance, and optimization of the clinical quality system, clinical regulatory requirements, and data integrity/quality
- Establish detailed program plans, drive program execution toward established objectives, assess risk and implement strategies to ensure successful delivery of the clinical objectives
- Direct and collaborate with internal and external staff, and liaise with partner sites and physicians, to ensure successful conduct of assigned clinical programs consistent with company objectives and applicable regulations and policies
- Development of protocols, statistical analysis plans, reports and other clinical study documentation
- Contribute to the overall strategic direction for development and implementation of clinical affairs objectives and processes
- Support and contribute to manuscripts, abstracts, data presentations, and health economic value initiatives
- Promote and embody culture and behavior expectations of a high-performance culture
- Drives leadership of issue identification and resolution
What You'll Bring:
- 5+ years direct clinical and regulatory experience in medical devices including some experience with Active Implantable Medical Devices.· Demonstrated success in designing and conducting clinical trials in support of medical device and/or pharmaceuticals· Experience with neurostimulation industry preferred
- Experience working with FDA and/or other regulatory and governmental agencies desire
- Experience in synthesizing complex clinical data into understandable written format
- A minimum of a Bachelor’s degree in science/biomedical/health related field; Masters or PhD preferred
- Ability to work effectively across time zones and cultures
- Ability to travel domestically (10% of time) and internationally
Where you'll work
Minneapolis, MNOn-siteOpen in Maps (opens in a new tab)
More jobs in Minneapolis, MNEqual opportunity, accessibility and legal noticesSaluda Medical Pty's statements, word for word
Saluda Medical embraces diversity and equal opportunity. We are committed to building a team representative of a variety of backgrounds, perspectives and skills. We believe people are the source of our inspiration and innovation.
Saluda Medical does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Saluda Medical’s approved agency list. Unsolicited resumes or candidate information submitted to Saluda Medical by search/recruiting agencies not already on Saluda Medical’s approved agency list shall become the property of Saluda Medical.
Job intelligence
The context around this role
Live data · November 4, 2026
Career trajectory
Where this role sits in Clinical Affairs
The general path across 20 open Clinical Affairs roles on Regulatory Jobs, with the titles they carry most. Not Saluda Medical's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership5
- Clinical trial conduct4
- GMP and compliance2
- Documentation and SOPs1
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Affairs work in medical devices, led by the one this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- ISOISO 14155(official source, opens in a new tab)Good clinical practice for clinical investigations of medical devices
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devices
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- FDAFDA Q-Submission Program(official source, opens in a new tab)Pre-Submissions and meetings with FDA on device submissions
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed device
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- FDAFDA De Novo(official source, opens in a new tab)Classification requests for novel low- to moderate-risk devices
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
From Regulatory News
Company hiring pulse
Saluda Medical on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 3
- Locations
By discipline
- Quality3 50%
- Clinical2 33%
- Regulatory1 17%
By level
- Senior & Principal3 50%
- Director2 33%
- Manager1 17%
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Manager, Clinical Affairs at Saluda Medical
Open until filled.