Associate Director, Safety Management

RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients - faster, safer, better.

We don't make MedTech. We make MedTech happen.

Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency.

Job Summary:

The Associate Director, Safety Management is a member of the core team responsible for safety and medical affairs oversight and leadership in accordance with SOPs, policies and corporate practices. The Associate Director, Safety Management is focused on staff leadership, mentoring and assisting delivery, productivity and quality resulting in strong performance and customer satisfaction. Additionally, the Associate Director supports the function with meeting department goals and identifying process improvement. The Associate Director, Safety Management, may be assigned their own studies, as part of their professional development while being primarily focused on staff development and support.

Primary Responsibilities:

• Responsible for activities related to safety management in medical device clinical studies. Works with clients to ensure RQM+'s operational processes are maintained while projects are completed within scope and budget.

• Manages team schedules and assigns tasks to ensure resource allocation is sufficient across projects.

• Ensures consistent use of study tools and training materials and compliance with standard processes, policies and procedures.

• Provides input to the maintenance and improvement of functional standard operating procedures, forms and templates.

• Coordinate, track and manage daily operations of clinical safety management team, including:

• Lead safety and vigilance activities for medical device and drug clinical trials, including adverse event (AE) and serious adverse event (SAE) assessment, documentation, and reporting

• Ensure appropriate evaluation of device-relatedness, expectedness, and reportability in accordance with applicable regulations and study protocols

• Monitor device deficiency and safety reports for trends requiring escalation to the Sponsor for Root Cause Investigation and support the collection and evaluation of information necessary to assess potential safety concerns.

• Oversee safety data review and trend analysis to identify potential safety signals and emerging risks

• Provide safety and risk management input to clinical trial protocols, Investigator's Brochures, informed consent forms, clinical monitoring plans, and risk management documentation

• Participate in internal and sponsor-led safety review meetings, Data Safety Monitoring Boards (DSMBs), Clinical Endpoint Committee (CEC) and clinical governance forums, as applicable

• Collaborate with Clinical Operations and Medical Monitoring to ensure consistent safety escalation and management processes

• Support development and maintenance of device risk management files in alignment with ISO 14971

• Assess safety trends and recommend mitigation strategies, protocol modifications, or corrective actions as needed

• Provides regular reports to management including resource utilization and Key Performance Indicators (KPIs).

• Contributes to safety team ongoing training and development.

• May serve as primary or back-up project Safety Manager.

• May assist in business development activities such as client introductory calls, attending bid defense meetings, budget development, etc. related to safety management.

• Supports audits, Sponsor and Regulatory, when needed.

• Responsible for performance appraisal of direct reports, and the implementation of performance plans if needed.

• Reviews and approves timesheet and travel expenses

• Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective direct report

• Works with direct reports on goal setting and tracking

• Seeks opportunities for growth and career advancement for direct reports

• Holds regular 1:1 meetings with direct reports

• Other tasks as requested to support the safety management department

Education/Work Experience/Requirements:

• Advanced degree preferred (MD, RN, etc.) with at least 8-years direct medical device clinical trial experience in a CRO or research-related organization with at least two (2) years management experience
• Global safety management experience (at least five years) within the medical device industry, with previous CRO experience is ideal
• Equivalent level of education and experience.
• Thorough knowledge of medical device clinical research process from pre-clinical through regulatory submission, approval and post-approval
• Strong communication skills (verbal and written) to express complex ideas.
• Excellent and demonstrated organizational and interpersonal skills
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
• Ability to manage multiple priorities within a variety of complex clinical trials
• Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings
• Ability to set baseline targets, track trends and implement mitigation plans
• Understanding of basic data processing functions, including electronic data capture
• Excellent verbal and written communication and presentation skills required
• Expert knowledge of current ICH GCP, ISO 14155 and ISO 14971 guidelines and applicable regulations
• Ability to work independently, prioritize and work within a matrix team environment is essential
• Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint
• Ability to establish and maintain effective working relationships with coworkers, managers and clients. Strong customer service skills
• Willingness and ability to travel domestically and internationally, as required

Behaviors: Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

Supervisory Responsibilities: This position will have supervisory responsibilities.

Work Environment & Physical Requirements:

This is a remote position. The employee is expected to maintain a dedicated, distraction-free home workspace with reliable high-speed internet access. Core working hours are determined by role responsibilities, client expectations, and business needs.

These requirements reflect what''s typically needed to perform the core functions of this role. If you require an accommodation to perform any aspect of this position, please let us know - we''re happy to discuss options.

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

Job Opportunity Verification:

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:

• All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers
• Every candidate going through the interview process will participate in a voice and/or video interview.
• Exercise caution with unsolicited job offers or requests for sensitive information.