Director of Regulatory Affairs and Quality Management (Remote)
Washington DC /
Altoida, Inc is making brain health smart and personal. Our innovative approach combines novel digital biomarkers (dBM) with immersive augmented reality (AR) and powerful artificial intelligence (AI). The result is a brain health platform built on more than 20 years of cutting-edge scientific research. Our products are backed by peer-reviewed publications and multinational clinical trials and are built by our passionate team of scientists, clinicians, and engineers.
Our Altoida family is united by 5 core principles:
1. We are data-first: data isn’t a buzzword to us, it’s at the core of our technology and in the DNA of our decision-making processes.
2. We are relentless: we know the impact our work will have on the world and are in pursuit of extremely lofty goals - we don't settle at “good enough.”
3. We are innovative: Our founders, executives, and early team members are united by a love of thinking differently and seeing groundbreaking ideas come to life.
4. We are thoughtful: From the way we treat each other to the way we unpack tough problems, we are considerate, respectful, and holistic.
5. We are adaptive: In a high-tech world, nothing is set in stone - we recognize and embrace that in our strategy and culture.
About the Role
The purpose of this position is to oversee all Regulatory Affairs and Quality Systems activities within Altoida.
As the Director of Regulatory Affairs and Quality Management, you will be responsible for all interactions with regulatory bodies and quality system activities within Altoida’s business. This role requires a seasoned operator with a working knowledge of medical devices and the regulatory bodies which oversee them. This position reports directly to the CEO and serves as both the Management Representative and the Person Responsible for Regulatory Compliance (PRRC) for the organization.
- Manage development and implementation of regulatory strategies for new and modified devices by preparing submissions and interface with FDA, notified body and other reviewing international authorities, and internal team members.
- Lead functional area within the business unit in the revision and/or development of processes/ procedures for new or revised regulatory requirements based on either change in the business or regulatory requirements.
- Develop personnel through daily interactions and coaching of staff, guide staff in technical and Regulatory matters, and effective business partnering with Marketing, R&D, and Clinical.
- Serve as a representative of the regulatory affairs function to improve awareness, visibility, and communication on regulatory requirements to support company goals and priorities.
- Advising on regulatory aspects of company strategy, regulatory assessments and classifications of potential products, and compliance readiness in different geographies
- Developing and Running Altoida's Quality Management System, including SOP design, training, management review, documentation, tools implementation, audits & certifications
- Well versed with international standards including, but not limited to, ISO 13485, ISO 14971, and IEC 62304.
- Overseeing and managing interactions with notified bodies and certification bodies.
- Overseeing the development of plans and responses to submission and inspection nonconformances.
- Overseeing remediation of any Quality or Regulatory gaps identified during internal audits, regulatory inspections, or third-party audits.
Required Skills & Experience
- 10+ years of industry, government, and/or notified body experience in conducting reviews, audits, or inspections of regulated products.
- Understanding of, and ability to analyze and apply regulations and standards related to international regulations
- Experience conducting and leading pre and post-launch activities for SaMD, (software as a medical device) and med device products
- Experience in the development and writing of technical files for Medical Device Regulations (EU MDR, FDA, PAL, TGA, etc.).
- Experience across FDA pathways (breakthrough designation, de novo, 510k, etc.)
- Basic knowledge of Clinical Evaluation / Investigation / Trial processes.
- Overall understanding of global medical device regulations and direct experience with the following types of submissions associated with US and EU Medicals Devices: 510(k) and EU Technical Documents required.
- Proficient working knowledge and analytical skills related to independently analyzing, interpreting, and applying International regulatory and quality regulations, guidance, and standards
- Self-directed and independent with the ability to perform with minimal direct supervision.
- Flexible, positive, clear interpersonal and communication skills with the ability to facilitate the exchange of information cross-functionally
- Capacity to adapt and lead others to understand and accept values, strategies, goals, and plans in response to changing business conditions.
- Prior experience in software design, engineering, or testing is preferred.
- B.A. or B.S. is required; a degree in Life Sciences, Engineering, or Computer Science is preferred.
Good to have
- Auditor qualifications (ISO13485, MDSAP, 21CFR820)
- Experience with eQMS Greenlight Guru
- Good Clinical Practices (GCP), and Quality System Inspection Techniques (QSIT)
- Strong understanding of global registration requirements and demonstrated track record of successful market access. Experience with NMPA in China
- General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices
We offer competitive total rewards compensation. Our commitment to our employees includes benefit programs that are comprehensive, diverse, and designed to meet the various needs across our employee population. Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through employee contributions. Specific benefit offerings may vary by location, position, and/or business unit.
The full-time salary range is commensurate with experience.
- 401(k) with matching
- Dental insurance
- Flexible schedule
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Altoida’s US headquarters is located in Washington, DC. The position is remote eligible, with minor travel expected.
Altoida does not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Altoida is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process.