SUMMARY: Manages the Regulatory and Quality System of the Company to support strategic objectives of the company ensuring compliance with regulatory body requirements including ISO, CE Marking, and FDA.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned:
- Supervise and direct the work of Regulatory and Quality Staff.
- Act as a mentor and leader for direct reports.
- Coach staff with all aspects of their responsibilities; develop a sense of urgency when key deliverables are jeopardized; facilitate problem-solving and meetings to address obstacles.
- Rely on core team members when faced with critical decisions; hold core team members accountable to program commitments.
- Proactively manage risks and employ strategies to address them.
- Actively work to promote team building and morale within the department.
- Foster teamwork; strive to maintain an environment of openness and trust.
- 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 record 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 the status of projects to CEO and other Management.
- Oversee 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, PMAs, Investigational Device Exemptions (IDE), and Humanitarian Device Exemptions (HDE).
- Ensure that the Regulatory department interfaces with key functional groups (Engineering, Operations, Sales, Marketing, and Clinical stakeholders) to drive company-wide or cross-departmental 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.
- Establish and maintain a professional and credible image with key physicians, consultants, vendors, and co-workers.
QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education & Experience
- 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 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.
Computer & Analytic Skills
- Must be able to assemble facts from various areas, analyze data, and provide informed recommendations to management.
- Must be able to work with minimal supervision, take charge of projects, and work effectively in a demanding, fast-paced environment.
- Must be excellent with technology, be able to present using a laptop computer, and demonstrate proficiency with MS Office package, including Excel, Word, and PowerPoint; as well as Outlook and Internet Explorer.
Physical Requirements
- Occasionally lift and/or move up to 25 pounds.
- Frequently required to sit; use hands to finger, handle, or feel; reach with hands; and talk or hear.
- Must be able to sit for long periods of time.
- The noise level in the work environment is usually mild.
- Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.
- Interaction with x-ray devices; for this reason strict safety and tracking programs are in place, requiring the utilization of dose monitoring equipment either full-time or as necessitated by situation.
Competencies
- 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 situations and prioritize factors in decision making.
- Self-motivated, utilize available resources for self-improvement and development.
- Flexible: able to follow directives and accomplish tasks outside of normal duties.
NeuroLogica is a Federal Contractor and an EEO/AA/Disability/Veterans Employer.
#J-18808-Ljbffr
