Director of Regulatory Affairs and Quality Assurance
4 days ago
We are seeking a highly experienced and skilled Director of Regulatory Affairs and Quality Assurance to join our team at NeuroLogica. The successful candidate will be responsible for managing the Regulatory and Quality System of the company to support strategic objectives and ensure compliance with regulatory body requirements.
Key Responsibilities- Supervise and direct the work of Regulatory and Quality Staff
- Act as a mentor and leader for direct reports
- Develop and implement regulatory & quality strategy and manage those systems and programs in order to meet corporate goals and objectives
- Coordinate department planning to ensure that the Regulatory & Quality department functions optimally and within the budget
- Review and advise on domestic & international product registration and licensing requirements
- Review and approve all engineering design changes and assess effectiveness of product realization
- Work with engineering team to develop new products as per required standards for global compliance
- Review and interpret regulatory rules as they relate to company products and procedures, clinical studies, testing, or records keeping and ensure that they are communicated through company policies and procedures
- Review all product labeling and marketing materials to ensure compliance with regulatory requirements
- Regularly report on status of projects to CEO and other Management
- Oversees the department SOP review and development, employee training, and associated requirements
- Manage activities related to supplier qualification, CAPAs, complaint handling, product performance and audits
- Communicate clearly (written and oral) with other company personnel, vendors, regulatory agencies, auditors, and the customer as required
- Serve as the liaison with FDA and other global regulatory agencies with responsibility for global regulatory submissions
- Prepare and review FDA applications and other regulatory documents including 510ks, PMA's, Investigational Device Exemptions (IDE) and Humanitarian Device Exemptions (HDE)
- Ensure that Regulatory department interfaces with key functional groups (Engineering, Operations, Sales, Marketing, and Clinical stakeholders) to drive companywide or crossdepartmental initiatives
- Participate in the short and long range planning of new product opportunities and participate in preparation of proposals
- Maintain knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to Samsung products
- Procure and oversee outside vendors and consultants as required
- Bachelor's in Engineering, Biological Sciences, or Related field preferred, Master's a plus
- Minimum 10 years regulatory experience in the medical device industry with a proven record of successful submissions to FDA of IDEs, 510(k)s, and PMAs preferred
- 4+ years management and leadership experience particular preferred; International regulatory experience desirable, including Europe, Asia, & South America
- Ability to communicate effectively with engineers, scientists, suppliers, and management through all media (in person, written, electronic - email, skype, and via telephone)
- Knowledge of product lifecycle, manufacturing processes, and supply management concepts
- Technically savvy; must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues
- Excellent written, oral, and documentation skills
- In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire
- High attention to detail
- Understanding of terminology and ability to share and communicate effectively within the group
- Ability to organize and prioritize tasks resulting in consistent productivity
- Ability to function within and support a team environment and build strong working relationships
- Dependable and punctual
- Ability to meet accuracy and productivity goals
- Good problem solving skills, ability to evaluate situation and prioritize factors in decision making
- Self-motivated, utilize available resources for self-improvement and development
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Danvers, Massachusetts, United States NeuroLogica Full timeJob Summary:As the Director of Regulatory Affairs and Quality Assurance at NeuroLogica, you will be responsible for managing the Regulatory and Quality System of the company to support strategic objectives. This includes ensuring compliance with regulatory body requirements, including ISO, CE Marking, and FDA.Key Responsibilities:Supervise and direct the...
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