At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients. Why work at Spacelabs? Because lives depend on you!
The Regulatory Affairs Manager is responsible for managing a team of regulatory specialists, coordinating and preparing applications and regulatory filings, assisting in the development of regulatory strategies, and participating in project teams by providing regulatory insight. This position reports to the Global Director of Regulatory Affairs. It requires a working knowledge of relevant international and US regulations.
Direct the activities of the Product Registration group.
Interface with appropriate Company personnel inside and outside the U.S. to ensure that international product registration and licensing requirements are met.
Work with project teams as regulatory representative to determine proper regulatory strategy based on project goals.
Maintain records of all registration activities and licenses and interface with Marketing personnel to assure the availability of product according to the Marketing Launch/Distribution plans.
Establish and update/maintain written procedures, on an ongoing basis, to ensure continued compliance with international regulatory and business requirements.
Assist in maintain integrated system post-market safety reports for devices.
Provide input on internal system, methods and intra departmental training to assure continual compliance with appropriate international regulatory requirements.
Maintain Product Registration Bluebook with latest Regulatory Intelligence for all countries where Spacelabs does business.
Monitor key performance indicators, assist in data collection for trending and report product availability to upper management as required.
Manage, evaluate and develop a team of employees to meet functional deliverables and responsibilities. Complete company people management requirements. Exhibit manager core competencies.
Assess department needs to recruit and train personnel; set standards of performance; select, appraise, train, and coach team members to meet performance standards.
Assist in preparing correspondence and timely responses to requests for additional information from OUS product license holders and regulatory agencies.
STEM Bachelor’s degree or equivalent experience and education.
4+ years’ experience in medical device industry dealing with US and international regulatory requirements.
2+ years’ experience leading or managing teams.
Demonstrated ability to communicate effectively over the telephone and in person with staff at all levels of the organization. Strong technical writing skills required. Ability to present to large audiences desirable.
Demonstrated proficiency with computer skills: MS Office applications, Agile PLM or other medical device quality or enterprise database systems.
Ability to multi task and drive practical results to a timely conclusion.
Experience/formal training in business/liability/risk management.
Project Management experience.
Knowledge and application of Medical Device Quality Systems, HIPAA requirements and other regulatory and quality standards.
Must be able to complete job responsibilities working with different time zone needs such as attending late night/early morning meetings by phone and/or web to meet global business needs: 15%.
Travel: Some travel is required <5%.
Company COVID-19 Vaccine Policy
To comply with applicable government requirements, all U.S. employees must be fully vaccinated against COVID-19 unless they are entitled to and approved for a legal accommodation, in accordance with the Company’s COVID-19 Vaccination Policy.
NOTICE TO THIRD PARTY AGENCIES
OSI Systems, Inc. and its subsidiaries (collectively “OSI”) does not accept unsolicited resumes from recruiters or employment agencies. If any person or entity, including a recruiter or agency, submits any information, including any resume or information regarding any potential candidate, without a signed agreement in place with OSI, OSI explicitly reserves the right to use such information, and pursue and/or hire such candidates, without any financial obligation to the person, recruiter or agency. Any unsolicited information or resumes, including those submitted directly to hiring managers, are considered and deemed to be the property of OSI.
Equal Opportunity Employer - Disability and Veterans
OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.
At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients.
Why work at Spacelabs? Because lives depend on you!