(Contract) Manager, Quality and Regulatory Affairs

Kymanox • Petersburg, VA

58d

About The Position

We are looking for a meticulous (Contract) Quality and Regulatory Manager to support one of our projects for 1 year based in Petersburg, VA.

Requirements

• 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).
• 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
• The ideal candidate will have a bachelor’s degree in a science-related field such as Biomedical Engineering, Mechanical Engineering, or Chemical Engineering.

Nice To Haves

• Medical Device RAC Certificate, preferred.
• AQC Quality Certificate, preferred.

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.

What This Job Offers

• Career Level: Mid Level
• Number of Employees: 251-500 employees