Manager, Safety Management Jobs

RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

The Manager, Safety Management provides safety expertise to clinical development programs for Sponsors at RQM+. Performs safety management activities with identification, triage and analysis of safety signals to define and or maintain safety profiles of high risk products and drive patient risk management. The role of the Safety Manager is to contribute to effective and efficient proactive safety strategies for the assigned processes and delivery of operational safety aspects. This includes the provision of key expertise and guidance to concerned Global Patient Safety functions and other functions within the company, as well as vendors for safety operational tasks. In addition, accountable for developing, optimizing, implementing, and documenting appropriate processes to ensure safety reporting compliance in the area of responsibility. Define

process KPIs, implement, monitor, and communicate performance and develop solutions for continuous improvements. Ensures sponsor’s and sites required compliance involved in pre and post market clinical trials for medical devices and combination products.

Responsibilities:

• Standard operating procedure (SOPs), Working Instructions (WI) reviews, inputs, knowledge, and implementation
• Investigator-sponsored studies (ISS) agreement review
• Act as an SME for the safety database
• CEC / DMC Coordination of activities and oversight
• Contribute to defining and implementing of clinical trial safety-related activities on behalf of RQM+ and its affiliates
• Contribute to the improvement of routine safety management activities throughout the product and process lifecycle
• Protocol review
• Responsible for Safety Management Plan, including review and oversight
• Request for proposals and Vendor Selection as it relates to Safety Management
• Safety Management Plan Ownership
• Overall Safety Management of RQM+ staff and associated sponsors clinical programs
• Informed Consent Form (ICF), review and input for safety-related sections

Requirements:

• Excellent and demonstrated organizational and interpersonal skills
• Ability to work in an intense, fast-paced, multinational work environment.
• Competent understanding of worldwide regulations relevant to the safety of medical devices in development and in post market setting
• Strong communication skills (verbal and written) to express complex ideas
• Working knowledge of all applicable safety and reporting regulations for high risk devices and combination products, globally
• Up to 20% travel may be required including international travel
• Ability to effectively communicate with employees, colleagues, and global teams
• Minimum 7 years of professional experience in medical device with 5 years in Safety of Clinical Trials
• Bachelor’s degree in medical or scientific related field
• Excellent verbal and written communication
• Customer and results orientation
• Positive motivator
• The ability to work independently, prioritize and work within a matrix team environment is essential. 
• Working knowledge of Word, Excel, and PowerPoint required. 

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.