(Contract) Manager, Quality and Regulatory Affairs
Description
Is Kymanox the right fit for you?
You want to make a difference and have an impact…
You enjoy having an influence in your day-to-day work…
You are motivated by working alongside a team filled with
subject matter experts who will help you learn and grow…
You wake up every day and do what you do
… because patients deserve better.
If this sounds like you, you’ve come to the right place.
We are looking for a meticulous (Contract) Quality and Regulatory Manager to support one of our projects for 1 year based in Petersburg, VA.
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.
Educational Background:
- The ideal candidate will have a bachelor’s degree in a science-related field such as Biomedical Engineering, Mechanical Engineering, or Chemical Engineering.
- Medical Device RAC Certificate, preferred.
- AQC Quality Certificate, preferred.
Experience:
- 10-15 years of experience working in Quality Assurance with medical devices and 5 years of Regulatory Affairs experience.
- Demonstrated level of experience in the combination product, and/or medical device sectors is required.
- 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).
Desired Aptitude and Skill Set:
- 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
Travel:
Up to 10% travel is possible.
Compensation:
Pay rate is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions.
About Kymanox:
Join Kymanox – a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.
Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, Philadelphia, and New Jersey.
To learn more about our company, please visit our website: Life Science Solutions | Kymanox
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.