Director of Regulatory Affairs and Quality Assurance

Director of Regulatory and Quality Assurance

Greater Boston ( hybrid role )

The ideal candidate will have experience in the medical device regulatory industry with a proven record of successful submissions to FDA of IDEs, 510(k)s, and PMAs; international regulatory experience (Europe, Asia, South America);and a solid background in managing a high performing team and demonstrated success in product life cycle management. Previous experience with medical imagining systems is highly desired.

This individual will manage 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.

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
• 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
  
  
  

Responsibilities:

• 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 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 company's 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
  
  
  

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 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
• 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 be able demonstrate proficiency with MS Office package, including Excel, Word, and PowerPoint; as well as Outlook and Internet Explorer
  
  
  

Apply online or direct email to the Recruiter- Judy Johnson @jjohnson@incendia.com. (Director, Requlatory) in subject line.