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Regulatory Affairs Project Manager
Why work at Spacelabs? Because lives depend on you!
This position will be responsible for the project management of all regulatory initiatives to expand product offerings into global markets. This involves coordination and alignment across multiple stakeholders including the global commercial sales team, regulatory, R&D, and program management to develop and execute plans to secure and maintain global markets for our products. This position will also support the regulatory and product registration activities of the company in global markets. This position may also support quality system update, regulatory compliance and submissions, as well as other continuous improvement projects.
****Remote work okay!****
- Develop and maintain effective global registration processes in alignment with business goals
- Manage multiple domestic and international regulatory expansion projects for new and existing products
- Coordinate, prepare and obtain necessary product clearances / approvals for complex regulatory submissions, domestic and international.
- Maintain a system to assure that all international product registration is current to assure product is continually and legally available in all local worldwide.
- Gather and present regulatory performance metrics on a regular and timely basis.
- Work as a strategic business partner with suppliers and business clients to proactively develop and implement practical, timely and effective business solutions to regulatory issues.
- Manage projects on changes to meet evolving worldwide medical device regulations, product registration requirements and standards.
- Create and manage communications with internal and external stakeholders on registration status and regulatory matters.
- Provide project management, general guidance and support to the RA department in all regulatory-related matters.
- Provide assistance and expertise during regulatory inspections.
- Continue to enhance the regulatory processes and procedures; create and revise work instructions and training as needed for these updates.
- Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork.
- Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct.
- It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
- Duties may be modified or assigned at any time to meet the needs of the business.
- Bachelor’s Degree is required. A BS with a technical / engineering background is strongly preferred.
- 5+ years regulatory experience within medical device industry.
- Proven track record of successful global regulatory registration for medical devices.
- International Regulatory registrations experience required.
- Demonstrated success in management of multiple projects, preferably regulatory submissions activities with various stakeholders.
- Regulatory Affairs Certification (RAC) is a plus.
- A strong sense of ownership and accountability for the success of projects.
- Knowledge of product development process and design control is desirable.
- Familiarity with a quality management system such as ISO 13485 is preferred.
- Ability to assist and advise with regulatory decisions.
- The ability to work independently and under pressure (able to prioritize tasks, deadline-oriented, and good organizational, problem-solving, and follow-up skills).
- The ability to communicate timely and clearly in writing and verbally at all levels and with all departments within and outside of the organization.
- Current working knowledge of Microsoft Word, Excel, PowerPoint & Outlook.
- Must be able to complete job responsibilities working with global time zone needs such as attending late night/early morning meetings by phone and/or web to meet global business needs, up to 5%.
- Some travel, domestic and international, up to 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
EEO is the Law
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.
Learn more here
Job posted: 2022-01-03