Program Specialist, Professional Education
Direct Hire Full-Time Role
Location : Santa Clara, CA - Hybrid Role
Duties and Responsibilities :
- Provide leadership to ensure the goals of the Professional Education Department are achieved.
- Share joint ownership and responsibility for all logistical aspects of professional education programs.
- Support efforts to transform how the medical community views lower back pain and SI-joint-related issues, helping position the company as a knowledge leader.
- Collaborate as a team member to achieve departmental goals in a compliant and consistent manner.
- Perform all duties in compliance with applicable worldwide regulatory requirements as outlined in the quality manual.
- Conduct all company business in an honest, ethical, and legal manner consistent with the company's Code of Conduct, the AdvaMed Code, and all applicable laws and regulations.
- Promptly report any suspected violations of laws, regulations, or company policies; retaliation in connection with good faith reports will not be tolerated.
- Manage the scheduling, coordination, and logistical setup of all HCP (Health Care Professional) training courses.
- Ensure pre-course information is distributed within appropriate lead times to effectively promote each course.
- Manage course budgets on a weekly basis to ensure compliance, appropriate resource utilization, and adherence to Sunshine Act reporting requirements.
- Maintain accurate data for training suppliers, materials, and course records.
- Manage inventory of training support materials, including creation or formatting as needed.
- Maintain detailed training records, budgets, spreadsheets, and related documentation.
- Procure national program approvals as required.
- Support and enforce all regulatory requirements.
- Provide general administrative support to the Professional Education Department.
- Perform lifting and packing of equipment (up to 50 lbs.).
- In cases of potential non-compliance with regulatory standards (e.g., FDA QSRs, ISO 13485, ISO 14971), hold any affected product or documentation and report to Quality, Regulatory, and management.
- Support and adhere to our quality system.
Requirements and Qualifications :
Minimum of 3 years' experience as a Program Specialist or Event Planner within a medical device organization-preferably in orthopedics or spine.A high level of professionalism, integrity, and discretion in handling confidential information.Strong organizational and communication skills, with the ability to manage multiple tasks and priorities effectively.Exceptional attention to detail and follow-through.Proven ability to work independently, take ownership of responsibilities, and deliver high-quality results within tight timelines.A proactive, problem-solving mindset with initiative, perseverance, and openness to new ideas.Ability to support or manage logistics for launching and maintaining professional education programs.Experience assisting in the development of performance metrics for departmental success and surgeon adoption rates.Proficiency in Microsoft Office applications and Salesforce.Confidence in interacting with physicians, executives, and both clinical and non-clinical hospital staff.Broad understanding of business operations, including R&D, training, clinical and regulatory, quality assurance, and strategic planning.Energetic, balanced, and results-driven attitude with accountability and teamwork.Familiarity with applicable standards and regulations (e.g., ISO 13485, FDA 21 CFR 820, EU MDR 2017 / 745, ISO 14971).Desired Skills and Experience
Program management, event planning, medical device industry experience, orthopedics, spine, professional education, HCP training, logistics coordination, scheduling, budget management, compliance, regulatory requirements, Sunshine Act reporting, FDA QSR, ISO 13485, ISO 14971, EU MDR 2017 / 745, 21 CFR 820, quality system management, training program development, course coordination, vendor management, inventory management, data management, record keeping, administrative support, Microsoft Office, Salesforce, physician relations, executive communication, clinical staff interaction, performance metrics, surgeon adoption tracking, strategic planning, R&D knowledge, quality assurance, documentation control, confidential information handling, organizational skills, communication skills, attention to detail, project ownership, deadline management, problem-solving, team collaboration, professional development, medical education, healthcare professional engagement, training material management, course promotion, pre-course communication, supplier management, national program approvals, lifting capability up to 50 lbs, hybrid work
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
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