We’re hiring! If you want your contributions to make a real difference, check out this new career opportunity with us at Draeger where we are led by the guiding principle “Technology for Life”.

In this role you will be:

Responsible for creating post-market surveillance strategy for all aspects of the Patient Monitoring business unit. In addition, responsible for the creation and ownership of the post-market surveillance policies, processes, and procedures, and for sustaining a center of excellence compliant to regulations, standards, and guidelines governing post-market surveillance activities for medical devices. Oversees the work of Post market Surveillance departments within Draeger Medical Systems Inc. Assures compliance activities are met which include managing customer complaints, determining adverse event and recall reporting eligibility, and maintenance of the Post Market surveillance system. Dedicated to driving quality improvement actions to ensure patient safety and customer expectations are met by optimizing Draeger Medical device performance, ensuring it is safe and effective.

Other duties include:

• Responsible for the management and oversight of Post Market Surveillance departments under the DMSI umbrella. Monitor department processes and workflow for opportunities for improvement and optimization. In conjunction with daily management responsibilities for work assignments / role accountabilities, talent acquisition (recruitment), and performance assessment / management, ensure effective workforce planning and talent development processes are undertaken to successfully contribute to the motivation, development, trust and collaboration needed to achieve annual goals and prepare for future needs. Monitor changes in regulations, standards, and guidance, and provide recommendations, and implementation plans for adherence to new or changing requirements. Develop function/area budget ensuring consistency with policies and controls. Manage and monitor all financial aspects to proactively address problems and ensure budget goals are met and return on expenses is maximized
• Manage the efforts of assigned investigators/sub investigators; including follow up actions to ensure timely and effective investigation results, provide direction as needed. Conduct staff meetings to monitor the status and progression of complaints under investigation.
• Determine if product/situation meets the Medical Device Reporting (MDR) and Medical Device Vigilance (MDV) requirements and reporting of these to FDA and other competent authorities. Prepare and submit required documentation to applicable regulatory bodies. Point of Contact for the FDA regarding questions about MDR or User Facility reports as well as Competent Authority inquiries.
• Responsible for conducting Field Actions and maintain Correction and Removal documents, product recall files, act as the correspondence for FDA and intentional Competent Authorities for safety relevant field actions. Is named as a proxy for the Director Competent Board, for which if the Director, Quality Assurance is unavailable, this role as authority to drive the decisions, document the results and initiate the resulting field action.
• Responsible to coordinate with cross functional teams to support the EU requirement for MDR regulation which includes managing and updating Post Market Surveillance (PMS) Plans and Periodic Safety Update Reports (PSUR) reports that describes the data sources and responsibilities to be monitored during product lifetime.
• Interface directly with Dräger functional departments, Regulatory offices, local subsidiaries, regional, field service personnel and clinical engineering personnel and complainant to effectively establish the cause of the quality issue and/or gather information to support the complaint investigation. Drive improvement projects regarding those tasks. Review analysis from C&D of customer issues to ensure customer expectations are met.
• Defines company policies in compliance with the global vigilance policy in the area of Medical Device Complaint Handling. Sets strategic policies to develop and maintain the Post Market Surveillance system at DMSI. Process Owner for various.
• Communicate across all applicable businesses to ensure post-market surveillance metrics are clearly visible and operations are maintained within a state of control. Drive Operational Excellence programs across the departments at DMSI.
• Performs other duties as needed and assigned.

Education:

Bachelor’s Degree preferably in scientific, healthcare, nursing, or related field.

Related Experience:

• Ability to foster a common vision which supports the organizations goals and focus on achieving long-term objectives; capability to orchestrate continuous change
• Proven success in building and leading teams, collaborating cross-functionally, and managing diverse thinking
• Extensive knowledge and understanding of current US FDA, MDD/MDR, ISO and CMDR regulations, standards, and guidance documents
• Experience with quality systems and regulatory compliance.
• Minimum, 8-10 years’ experience in working with regulatory agencies
• Previous experience in adverse event reporting and managing recalls

Special Competencies or Certifications:

• Demonstrated leadership skills to manage department and to drive complaints to closure
• Able to exercise sound judgment within Draeger using standard operating procedures and policies to determine appropriate action to achieve objectives
• Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment
• The individual must possess excellent verbal and written communication skills
• Must be well organized and able to multitask effectively, as well as show assertiveness, when interfacing with other personnel
• Knowledge of current ISO 9001, ISO 13485, SMDR SOR/98-282, MDD 93/42/EEC, J-GMP and 21 CFR Part 11, 803, 806, 820, EU-MDR, MDSAP

Work Environment / Conditions:

• Able to work in a dynamic, fast paced, high activity office environment.
• Ability to use computers and computer systems (includes hardware and software)
• Ability to travel up to 25% of the time (by automobile, train, plane)

This role is based out of our beautiful Andover, MA facility which offers many benefits including an on-site fitness center with yoga and fitness training classes, on-site game rooms, full-service café, free parking and more. Andover supports the design and assembly of our patient monitoring products.

Benefits
Dräger is responsible for life. The lives of our employees are especially important to us, therefore, Dräger believes in fostering a culture that places the focus on employee health & wellbeing, both in the office and at home. We offer a generous benefits package that includes, comprehensive medical, dental & vision coverage, paid time off starting at 4+ weeks per year, tuition reimbursement, 401k match, wellness and employee support programs, life insurance and more!

Locations

Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario.

EEO is the Law

Draeger is an Equal Opportunity Employer. To learn more: Know Your Rights: Workplace Discrimination is Illegal (dol.gov)

From hospitals to fire departments to industrial customers, people around the world rely on our products: cutting-edge technology that combines real engineering with the digital future. With over 130 years of experience, passion and the bold ideas of more than 16,000 employees, we are committed to turning technology into ›technology for life‹.

• Health Insurance
• Health center and gym
• Retirement savings