Principal Regulatory Affairs Specialist
Sorry, this particular job is closed. But feel free to fill out a General ApplicationSearch Jobs
Principal Regulatory Affairs Specialist
Title: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.
- Assembly in Brooklyn Park MN
- EM Assembler in Holliston MA
- Stockroom Associate in Norcross GA
- Electrical Engineer - Medical Device in Wayzata MN
- Field Applications Engineer in san jose CA
- Test Technician in Chaska MN
- Welder in Duluth GA
- Associate Videographer in Milford MA
- Systems Aeronautical Engineer in Bloomfield CT
- Mechanical Aeronautical Engineer in Bloomfield CT
- NDT Level II in Bloomfield CT
- Electrical Engineer III in Alpharetta GA
- Quality Engineer in Gainesville GA
- Material Handler (Production) 8-21-19 in Westborough MA
- Electrical Engineer in Providence RI
- Electromechanical Assembler in Norwood MA
- Payroll Specialist in Waltham MA
- Mechanical Assembler in Duluth GA
- Field Service Specialist in Milford MA
- Welder 2nd Shift in Alpharetta GA
- Shipping-Receiving Clerk in Marlborough MA
- Optical Assembly Technician in Nashua NH
- Maintenance Mechanic in Memphis TN
- CNC Polishing Technician in Nashua NH
- Quality Inspector in Kennesaw GA
- Principal Mechanical Engineer in Nashua NH
- Principal Optical Engineer in Nashua NH
- Optician in Nashua NH
- Assembly-Testing in Flowery Branch GA
- Quality Engineer in Memphis TN
- Assembly Technician in Worcester MA
- Material Handler 1st shift in Westborough MA
- Mechanical Assembler in Peabody MA
- Process Quality Engineer in Fall River MA
- Sr Systems Engineer in Providence RI
- Quality Assurance Engineer in Duluth GA
- Client Services Representative in Cleveland OH
- Material Handler (Production) 8-14-19 in Westborough MA
- Electronic Technician in Memphis TN
- Senior Quality Inspector in Alpharetta GA
- Electronic Assembler III in Alpharetta GA
- Senior Electrical Engineer in Alpharetta GA
- Customer Account Specialist in Hopkinton MA
- Electronics Test Tech in Suwanee GA
- Picking - 2nd Shift in Suwanee GA
- Quality Inspector-CMM Programmer in Lawrenceville GA
- Power Electronics-Test Lab Technician in lowell MA
- Engineering Support Coordinator in Norwood MA
- Account Representative in Collierville TN
- Customer Service Rep in Flowery Branch GA
- Technical Service Administrator in Milford MA
- Financial Analyst II in Milford MA
- Buyer -Planner in Andover MA
- Maintenance Mechanic in Alpharetta GA
- Roll Thread Operator in Alpharetta GA
- Administrative Assistant in Tampa FL
- Soldering in Suwanee GA
- Sr. Manufacturing Technician in Littleton MA
- Mechanical Assembler-Forklift Operator in Buford GA
- Structural Designer in Decatur AL
- I&E Designer in Decatur AL
- Fabricator - Weld Cleanup in Lawrenceville GA
- Materials Associate in Marlborough MA
- Tool and Die Maker in Alpharetta GA
- Customer Care Representative in Center Valley PA
- Research Associate in Milford MA
- Project Manager in Mansfield MA
- Forklift Operator in Buford GA
- Material Handler (Production) 8-7-19 in Westborough MA
- Maintenance Mechanic - 2nd shift in Lincoln RI
- Project Manager in MA
- Waterspider in Memphis TN
- Mechanical Inspector in Woburn MA
- Industrial Motor Assembly Technician in Suwanee GA
- Entry Level Product Engineer in Lawrenceville GA
- Material Handler (1st Shift) in Franklin MA
- Logistics Coordinator in Memphis TN
- Service Technician in Duluth GA
- Senior Manager Supply Chain Solutions in Atlanta GA
- AWS Certified MIG Welder in Flowery Branch GA
- Field Systems Tech in Beverly MA
- PLC Engineer in Mansfield MA
- Quality Inspector in Methuen MA
- Marketing Transformation Specialist in Milford MA
- Electrical Engineer in MA
- Repair Technician in Minneapolis MN
- Mechanical Designer in Roswell GA
- Jr Buyer in Merrimack NH
- Technology Services Coordinator in Duluth GA
- Systems Qualification Scientist in Milford MA
- HR Admin in Hopkinton MA
- Project Manager in Suwanee GA
- Mechanical Inspector in Hopkinton MA
- CNC Machine Operator in Flowery Branch GA
- Assembler IV in Methuen MA
- Field Service Technician in Loganville GA
- Test Technician Supervisor in Tucker GA
- Quality Control Inspector in Methuen MA
- Assembler II in Milford MA
- Chemistry Technician I in Golden CO