Director of Quality & Regulatory-Medical Device/IVD-Dedham, MA
Leadership opportunity within a growing analytical instrument company
Assist in building out a team projected for 20% growth
About Our Client
Our client is the world's largest manufacturer of freezing-point osmometers used in clinical, pharmaceutical, and biotechnology laboratories. Our client is also a leading supplier of analytical instruments and test kits for the food, dairy, and industrial microbiological markets and has technical expertise in cytology, image analysis, and infrared spectroscopy. Their products are supported by a worldwide network of direct sales people and distributors, and 24/7 technical support.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Quality & Regulatory Director is responsible for
- Provide QA/RA leadership across all departments, giving input to senior management, for product and process improvements.
- Act as the Management Representative for the Quality Management System.
- Train company employees on compliance with quality system standards such as 21 CFR 820 and ISO 13485.
- Participate with the management team in developing and implementing relevant business and strategic plans.
- Ensure company is regulatory inspection ready at all times (FDA, Notified Body, international regulatory bodies, customers).
- Plan, coordinate and direct regulatory strategies for new products.
- Manage regulatory affairs, quality control, quality assurance, supplier quality, calibration, complaint handling and document control staff.
- Direct investigations and implement corrective actions to resolve complaints and non-compliance instances.
- Develop and implement quality system management strategies and plans to include resources, systems, timelines and financials that support, contribute to and integrate with company's annual and long term strategy.
- Manage all certifications and product approvals (i.e. MDSAP, ISO9001, etc.)
A much more in depth job description will be provided upon application and consideration. Please submit your resume for consideration within 48 hours. Relevant candidates can expect to hear back within 48 hours of submission
The Successful Applicant
The successful Quality & Regulatory Director will have
- Extensive knowledge of ISO 13485, QSR and CE marking.
- Ten plus years of regulatory compliance/quality systems/regulatory submissions experience in Class 1 and Class II medical devices required.
- Experience with in vitro diagnostics (IVD) is preferred, other applicable experience is a plus.
- Five to seven years' experience as a Manager or Director.
- Demonstrated effective leadership ability and experience.
- Demonstrated ability to effectively manage multiple priorities in a fast-paced deadline-driven environment.
- Strong organizational, written and verbal communication skills.
What's on Offer
If you are interest in this position, please contact me at or you can directly apply below. This position included a competitive salary and bonus structure that is comparable with current salary and experience.