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Director, Regulatory Affairs and Quality Assurance, Employment | ASCE
Director, Regulatory Affairs and Quality Assurance
BiOM is transitioning prosthetics into Personal Bionics. The company produces bionic propulsion technology to replace lost muscles and tendons. The BiOM T2 System provides power assist to enhance the mobility of people with lower limb amputations. Personal bionics will one day help people whose mobility is limited by stroke, diabetes or other conditions of disease and age.
Privately held and headquartered in Bedford, Mass.
BiOM is a late stage, venture-backed start-up that has taken ground breaking research in the area of gait normalization, developed at the MIT Media Lab, and has turned it into a revolutionary prosthetic product for lower-extremity amputees.
The BiOM T2 is a robotic ankle/foot system that emulates the biological Achilles tendon and calf muscles and provides powered plantar flexion (push-off) during walking. The addition of this powered plantar flexion has been shown to normalize the metabolic energy used in walking between an amputee’s affected and disaffected sides.
As we continue to push this product towards commercialization, we have an immediate need for a Director, Regulatory Affairs and Quality Assurance with clinical experience. This new addition will be responsible for leading the activities of the RA/QA team and providing guidance and leadership to the organization, to ensure Quality System and Regulatory compliance. Key to this role is to ensure customer requirements are met and quality improvements are driven.
The ideal candidate will have strong leadership and clinical RA/QA experience with a Class II or III medical device industry. You will be fluent in quality management systems, regulatory compliance, risk management, and ISO 13485 compliance.
The chosen candidate will fancy themselves a passionate and response leader. They will be a high-powered leader that thrives when working as part of a tightly integrated team.
- Oversee and manage BiOM’s Quality and Regulatory team (QA Specialist and Document Control Specialist);
- Manage quality and regulatory strategic initiatives as part of departmental and corporate goals and objectives;
- Ensure organization remains complaint to the latest revisions/changes of all applicable regulations and standards.
- Manages total quality programs, policies, and initiatives;
- Responsible for identifying, analyzing and developing improvements in productivity, quality, client relationships, and customer service;
- Approve training materials for cGMP’s, Quality System, Regulatory compliance, Risk Management, ISO 13485 compliance;
- Partner with Manufacturing and Engineering to ensure timely resolution of quality issues;
- Management Representative for ISO certification management reviews;
- Fulfill responsibilities as BiOM’s Management Representative with the FDA;
- Corporate liaison to regulatory agencies;
- Work with Manufacturing on strategic supplier selection, development, and management;
- Carry out all responsibilities in an honest, ethical and professional manner;
- Exercise good judgment in the use of company funds to ensure profitability;
- Comply with both the spirit and letter of applicable laws and regulations;
- Maintain confidentiality of company data including new product information and other business proprietary information;
- Demonstrate BiOM’s core values of integrity, determination and excellence;
- Uphold BiOM’s level of professional conduct;
- Other duties as assigned.
- Minimum of 5-10 years in a similar role in the medical device industry with clinical experience a plus;
- BS in Engineering, or equivalent industry experience;
- Excellent communication skills, both written and verbal;
- Have excellent interpersonal skills including the ability to work across the organization;
- Be organized and able to multi-task in a fast paced environment;
- Adherence to all safety and quality requirements ;
- Must be a hands-on team player ;
- Be able to develop improvement strategies and implement solutions;
- Experience in applying concepts of lean manufacturing and other process improvement activities;
- Possess excellent computer skills;
- Strong oral and written communication skills;
- Ability to work in an agile, start-up environment as an individual contributor and member of a multidisciplinary team ;
- A love for tackling technical challenges and a passion for making a big difference in the quality of life for many thousands of people.
Additional Salary Information: Competitive Base, Bonus, Benefits, and Incentive Stock Options
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