Kymanox · 22 hours ago
(Contract) Manager, Quality and Regulatory Affairs
Petersburg, Virginia
Full-time, Contract
Onsite
Senior Level, Lead/Staff
10+ years expKymanox is a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. They are looking for a meticulous Contract Quality and Regulatory Manager to support their projects, focusing on regulatory strategies and quality assurance for medical devices.
Life ScienceTechnical Support
Responsibilities
Develops and directs regulatory strategies for 510(k) and CE Marked medical devices
Develops, supports, and maintains the 510K) submission to the FDA. This may include clinical data, nonclinical data, design history files, and other technical documentation against industry regulations and standards (US/EU/ROW)
Provides onsite senior leadership to project teams with accountability for project strategy, execution, success, and client satisfaction
Leads planning and execution of quality assurance events (e.g. CAPA, NC, Deviations, Complaints, Training, Audits, etc.)
Leads the effort to develop a QMS that is compliant to 21 CFR 820/QMSR, ISO 13485 and MDR 745/2017
Evaluates future business needs and derives/implements strategies to meet those needs
Qualification
Required
Bachelor's degree in a science-related field such as Biomedical Engineering, Mechanical Engineering, or Chemical Engineering
10-15 years of experience working in Quality Assurance with medical devices
5 years of Regulatory Affairs experience
Demonstrated level of experience in the combination product, and/or medical device sectors
Familiarity with risk management tools and applications as well as data analysis tools and applications
Strong knowledge of medical device regulations and standards, including FDA regulations and ISO 13485 and GMP
Demonstrated experience of preparing US FDA/EU EMA submissions (e.g. 510(k)/DeNovo/PMA, Design Dossiers/CE Mark)
Working knowledge of Quality System requirements (21 Part 820/QMSR and ISO 13485)
Working knowledge of ICH guidelines for CTD, GMPs, clinical quality requirements
Working knowledge of design controls (21 CFR 820.30)
Working knowledge of device risk management (ISO 14971/ISO TR 24971)
Detail-oriented
Strong organizational skills and verbal/written communication skills
Highly motivated self-starter with a sense of ownership and willingness to learn
Thrive in a fast-paced, growing, and dynamic work environment
Ability to form partnerships with internal stakeholders
Seasoned soft skills (i.e., high EQ)
Technology savvy
Preferred
Medical Device RAC Certificate
AQC Quality Certificate
Company
Kymanox
Kymanox is a technical products & project management company provides engineering, scientific, regulatory, and process operations support.
201-500 employees
H1B Sponsorship
Kymanox has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (1)
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
unknown2021-08-23Debt Financing
2021-08-02Series Unknown
Leadership Team
Stephen M. Perry
CEO
Nicholas Ciccarelli
Chief Technology Officer
Recent News
EIN Presswire
2025-05-08
GlobeNewswire News Room
2024-11-29
Company data provided by crunchbase