Regulatory Affairs Manager
Chicago, IL, USA
Posted on Friday, December 29, 2023
Cardiosense is a digital health company that operates at the intersection of wearable technology and artificial intelligence to improve patient health. Our mission is to use physiological waveform data to predict cardiac illness and enable early interventions so people can enjoy healthier, longer lives.
To achieve our mission we are building a physiological waveform AI platform to develop predictive biomarkers to detect and manage cardiac disease. The company has developed a suite of novel digital tools, multi-sensor devices, and analysis algorithms for use by care providers to detect clinical worsening earlier, inform personalized therapy, and improve patient outcomes.
Our team brings together experts in data science, electronics, and healthcare and has partnered with leading healthcare and academic institutions to introduce the next generation of patient waveform monitoring and analytics solutions.
We are looking for an Individual who is creative, forward-thinking, and who approaches challenges with an innovative attitude. We take pride in hiring the best and brightest minds.
The Regulatory Affairs Manager will be responsible for managing US FDA submissions (510k and DeNovo) and cross-functional activities related to the design and development of Cardiosense Software and Hardware and AI/ML algorithms. This role will require direct and hands-on experience of authoring 510(k)s as well as supporting the cross functional team to populate relevant supporting documentation. The candidate will also support the development and implementation of FDA QSR, EU MDR (EU 2017/745) and ISO 13485: 2016 under MDSAP QMS, and applicable international regulatory compliance activities.
Essential Duties and Responsibilities:
- Help the company and support the VP of Regulatory/Compliance with implementing regulatory strategies for various Cardiosense hardware, software, and AI/ML products.
- Manage all aspects of US FDA and CE marking activities for the specified projects by driving the creation, assembly, compilation, review, and submission of technical documentation such as Technical Files, Design Dossiers including the General Safety and Performance Requirements (GSPRs) to obtain product approvals, licensing, and registrations and post-market follow-ups including amendments/supplements related to clinical trials under applicable country-specific regulations.
- Support both internal change assessments and external regulatory change notifications including regulatory responses and agency interactions.
- Oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
- Interacts with regulatory agencies to expedite submissions and/or approval of pending registrations.
- Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management.
- Assist clinical operations and ensure clinical study results and reports are suitable for regulatory submissions.
- Responsible for adverse events (Vigilance) and field correction (Advisory Notice) reporting and assessments of AEs to determine “reportable” events. Provide regulatory support as required in the evaluation of product complaints and ensuring AE reports meet regulatory requirements.
- Establish and maintain regulatory processes in accordance with MEDDEV, ISO, and applicable US and international regulatory requirements.
- Participates in product plan development and implementation, regulatory strategy, product labeling, risk management, post-market surveillance and post-market follow-up cross functional activities.
- Ensure alignment of regulatory strategy to business strategy across all functional areas including timely approval of new medical devices and continued expansion approvals of marketed products.
- Serves as regulatory representative to marketing, clinical, research teams and regulatory agencies.
- Accountable for ensuring that regulatory submissions and technical documentation meet appropriate standards, guidance, and content requirements.
- Write regulatory justifications to support design changes and submission filing decisions.
- Carry out responsibilities in accordance with the organization’s policies and applicable laws.
- Support the company’s Quality Policy and Quality Management System.
Education and Experience:
- Bachelor’s degree in a life sciences, engineering, or technical related discipline.
- 8 to 10 years of experience in Regulatory Affairs in the medical device industry
- Experience with both high-risk device and non-significant risk device classes
Skills, Abilities, and Other Requirements:
- Experience with health authority meeting preparation, interaction, responses, and issue resolution.
- Solid understanding and proven practices within both EU MDR 2017/745, ISO 13485: 2016 and FDA QSR regulations.
- Familiar with both FDA Electrosurgical Guidance and IEC 60601 Electrical Safety and EMC requirements.
- Proven ability to independently manage critical projects as part of an interdisciplinary team. In addition, the candidate should have hands-on experience preparing, managing, and submitting major regulatory submissions.
- Ability to use online tools such as SmartSheet, MS Teams, Zoom to manage multiple and simultaneous projects and navigate challenges to deadlines.
- Excellent oral and written communication skills and critical thinking skills.
- Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
- Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast-growing company.
What will make you a preferred candidate:
- Previous experience or knowledge of working with digital health and AI/ML products.
- Engineering degree in technical fields
- Knowledge of Global regulatory is a plus.
Cardiosense is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, religion, disability status, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.