The Director Regulatory Affairs must be a strategic thought partner to the platform lead supporting the growth agenda in key strategic initiatives. They must collaborate effectively with R&D, Marketing, Medical Affairs, Quality and other functional areas to provide regulatory expertise to effectively develop regulatory strategies that successfully lead products through the FDA clearance and approval process, as well as other global regulatory agencies.
Essential Job Functions:
- Develop, manage, and execute the Company’s global regulatory strategy.
- Recruit, manage, develop, and mentor regulatory professionals.
- Prepare and manage department annual budgets.
- Provide regulatory input and guidance to product lifecycle planning and new product development teams.
- Lead the preparation, submission, and review process for FDA 510(k) product clearance.
- Lead the preparation, submission, and review process for global product registrations
- Monitor global regulatory landscape and advise Company management on impact to regulatory strategy.
- Maintain required annual licenses, registrations, and listings required to support the Company’s commercial strategy.
- Review and approve product labeling, advertising, and promotional items to ensure compliance with regulations and company policy.
- Assess external communications relative to regulations.
- Provide regulatory input for and appropriate follow-up to inspections and audits.
- Oversee regulatory input and approval of change control to confirm regulatory compliance.
- Provide regulatory input for product recalls and recall communications.
- Provide training for employees on current and new regulatory requirements to ensure company-wide compliance.
- Strategize with and advise internal stakeholders on regulatory issues and requirements.
- Required - Bachelor of Science degree in a technical discipline (e.g., biology, chemistry, or engineering); Advanced degree preferred
- 10 years of progressive regulatory affairs experience including a minimum of five years of management experience
- Demonstrated experience of successfully leading the submission and clearance of FDA 510(k) products
- Demonstrated experience with regulatory documentation and approval of ISO 13485 Class 2 medical devices
- Demonstrated experience with global regulatory product approvals
- Working experience in a medical products design and manufacturing environment
- Regulatory experience with drug delivery devices and /or pharmaceuticals preferred
- RAPS Regulatory Affairs Certification (RAC) preferred
- Extensive knowledge of applicable government regulations.
- A proven track record of recruiting, developing, and retaining a high-performance team
- Proven ability to deliver results under tight deadlines
- Excellent analytical, problem-solving, and critical thinking skills
- Ability to lead, influence and communicate with diverse cross-functional teams
- Excellent writing, presentation skills; strength in Excel and PowerPoint
DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Therefore, employees assigned may be required to perform additional job tasks required by the manager.
We maintain a drug-free workplace and perform pre-employment substance abuse testing.
KORU Medical Systems provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, marital status, pregnancy, parental status, national origin, ethnic background, age, disability, political opinion, social status, veteran status, union membership or genetics.
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