Training & Document Ctrl Lead

Job Summary

The Training & Document Control Lead supports and implements DeepHealth's training and development program for internal and external training needs, with a particular focus on Quality Management System and Information Security requirements. Reporting within Quality, Regulatory, and Compliance, this role partners across the organization to identify training needs, develop materials, deliver or coordinate training, and maintain accurate training records that support regulatory and operational compliance. This position does not include people management responsibilities.

Essential Duties and Responsibilities 

• Work cross-functionally to identify training needs and development plans for DeepHealth teams and individuals.
• Design and develop training materials and programs aligned to team roles and responsibilities.
• Select appropriate training methods and activities for the material being delivered.
• Execute training programs that support compliance with applicable laws and regulations for markets where DeepHealth products are marketed and distributed.
• Assess instructional effectiveness and the impact of training on employee skills.
• Gather feedback from trainers and trainees and use it to improve programs.
• Partner with internal stakeholders on instructional design for QMS, Information Security, and related compliance training.
• Maintain updated curriculum databases and training records in the Learning Management System and related systems.
• Research and recommend new training methods and tools to improve delivery and compliance readiness.
• Support audit readiness by ensuring training documentation is complete, current, and accessible.

PLEASE NOTE: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above.  Other functions may be assigned and management retains the right to add or change duties at any time.

Minimum Qualifications, Education and Experience

• Bachelor's degree in a relevant field, or equivalent practical experience (for example, an Associate's degree with 3 years of related experience) (required).

Minimum of 2 years of experience in a regulated industry (required); medical device experience preferred.

Proven experience as a Training Coordinator, Trainer, Training Facilitator, or similar role (required).

Experience with Learning Management Systems, web delivery tools, and multiple training methods, including e-learning (required).

Excellent written and oral communication skills (required).

Preferred: Software and/or Software as a Medical Device experience.

Preferred: Knowledge of FDA Quality System Regulations and ISO 13485.

Preferred: Experience supporting regulatory agency audits.

Quality Standards

• Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, co-workers, visitors, and vendors.
• Demonstrates initiative, personal awareness, professionalism and integrity, and exercises confidentiality in all areas of performance.
• Follows all local, regional and country laws concerning employment.
• Follows all DeepHealth policies and procedures.
• Follows data privacy, compliance, safety and confidentiality standards at all times.
• Practices universal safety precautions.
• Promotes good public relations on the phone and in person.
• Adapts and is willing to learn new tasks, methods, and systems.
• Reports to work regularly as scheduled; consistently punctual with respect to working hours, meal and rest breaks, and maintains satisfactory personal attendance in accordance with DeepHealth guidelines.
• Completes job responsibilities in a quality and timely manner.

Travel

This position may require travel up to approximately 20%.

Working Environment

Remote

Physical Demands

The employee must be able to perform the essential duties and responsibilities of the position, with or without reasonable accommodation.