Principal Regulatory Affairs Specialist
Principal Regulatory Affairs Specialist
The DAVIS Companies is supporting a pioneer for interventional and diagnostic technology by securing a Principal Regulatory Affairs Specialist.
The Principal Regulatory Affairs Specialist provides the overall regulatory strategy (as applied to project, process, and/or product) and partners with internal stakeholders (e.g., regions) to align on an optimized regulatory strategy in order to achieve business objectives and government compliance. This individual proactively evaluates existing and emerging regulatory and quality requirements and directs implementation activities to minimize business exposure and guidance for interactions with government officials. Provides global regulatory support.
Primary Duties and Responsibilities of Principal Regulatory Affairs Specialist:
- Develop and prepare regulatory plans, submissions; 510(k) Premarket Notification, EU Submissions, Australian Submissions, Canadian Licensing, Japan submissions. Also, coordination of staff support for worldwide registrations for global growth and expansion.
- Participate as regulatory representative on project teams, communicate regulatory requirements and strategy.
- Prepare and conduct meetings / teleconferences with external regulatory agencies as assigned. Communication with government regulatory agencies and Notified Bodies and serve as regulatory liaison on the project team throughout the product lifecycle.
- Provide strategic product direction to product teams and cross functional partners to advise on global medical device regulation.
- Maintain all regulatory files ensuring documentation, registers, directories and lists are complete and up-to-date.
- Ensure that compliance to standards, pre-clinical and clinical study designs meet regulatory requirements.
- Review, edit and approve project documentation as the active regulatory representative on project teams.
- Mentorship and development of junior regulatory staff and training for cross functional partners.
- Review of device labeling in all forms and advertising materials for compliance with FDA submissions and applicable regulations; analyze and recommend appropriate changes.
Qualifications of Principal Regulatory Affairs Specialist:
- BA degree in Science or Engineering
- Minimum of 8-10 years of experience in Regulatory Affairs
- Minimum of 6 years medical device industry experience including strong 510(k) submission experience, EU CE Mark submissions, Health Canada submissions, and international market submissions.
- Strong working knowledge and experience with quality systems regulations and guidelines, ISO, GMP, Medical Device Directive (MDD)/Medical Device Regulations (MDR) and FDA regulatory requirements.
- Skill in determining alternatives that would correct a situation to comply with standards and regulations
- High level of planning and organizational skills
- Demonstrates ability to coordinate and work effectively with multiple stakeholders.
- Ensures timely, clear communications to internal stakeholders on project status and issues.
- Serves as role model and embraces corporate Values and Behaviors
- Demonstrates good organizational and time management skills, including the ability to work on multiple projects and adhere to timelines.
- Meets individual goals as defined in the annual objectives.
- Ability to support the business by communicating effectively, managing issues proactively, resolving conflicts and mitigating risks.
- Ability to work in a matrixed environment and influence internal partners to achieve desired business outcomes.
- Strong writing skills in the form of high-quality regulatory submission documents.
- Commits to driving efficiency while maintaining quality.
- Drives superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments.
- RAC Certification.
- 8 years or greater of experience in medical device industry.
- 10 plus years working in Regulatory Affairs.
- Strong FDA, Health Canada, TGA, PMDA, EU, and international market submission experience.
- Demonstrated ability in project management skills in order to plan, conduct and implement system assessments and robust submissions.
- Working knowledge of clinical trial strategy and study design, statistical methods and data reporting.
- High level of planning and organizational skills.
- Effective research and analytical skills.