Regulatory Affairs Specialist II

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 Specialist II supports the regulatory and product registration activities of the company. This role involves working closely with high-priority regulatory activities, such as MDSAP regions and other primary market registrations. The specialist will collaborate with design control teams to assess the impact of product changes on regulatory obligations and assist in reviewing reported issues for potential adverse events. Additionally, the role includes preparing regulatory documentation for global submission. This RA Specialist will provide technical guidance to team during the course of submission preparation and interaction with regulatory agencies.

***This position is hybrid/ remote, with the expectation of working onsite 1-2 days per quarter.***

• Coordinate, prepare, and obtain necessary product clearances for moderately complex regulatory submissions, both domestically and internationally.
• Maintain a system to ensure all international product registrations are current, ensuring products are legally available worldwide.
• Review reported issues for potential adverse events, prepare reports, and submit them to appropriate government bodies.
• Prepare required Field Action Plans, Customer Letters, and government notifications as directed.
• Stay current on changes to worldwide medical device regulations, product registration requirements, and standards, and inform the RA team.
• Gather and present regulatory performance metrics regularly.
• Manage communications with external agencies and parties on regulatory matters.
• Actively participate as the regulatory representative in engineering project, product, and process meetings.
• Provide input on, review, and approve product and labeling changes for compliance with standards, guidelines, regulations, and regulatory approvals/clearances.
• Implement global regulatory action plans based on product and labeling changes.
• Provide general guidance and support to the RA department in all regulatory-related matters.
• Assist and provide expertise during regulatory inspections.
• Ensure the effectiveness and currency of the Quality Management System, including adherence to the Quality Manual and supporting Standard Operating Procedures.
• Enhance regulatory processes and procedures; create and revise work instructions and training as needed.
• Communicate with customers on sensitive regulatory matters.
• Work as a strategic business partner with suppliers and business clients to develop and implement practical, timely, and effective business solutions to regulatory issues.
• Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrate behavior consistent with the company’s Code of Ethics and Conduct.
• Report any quality problems or defects to management to ensure corrective action and prevent recurrence.
• Duties may be modified or assigned at any time to meet the needs of the business.

• Secondary Responsibilities:

  • Support the Environmental Health and Safety (EHS) system by ensuring compliance with relevant regulations and standards.
  • Assist in the development, implementation, and maintenance of EHS policies and procedures.
  • Participate in EHS audits, inspections, and help address any identified issues.
  • Support the Security and Privacy Program by ensuring compliance with data protection regulations and company policies.
  • Assist in the development and implementation of security and privacy policies and procedures.
  • Participate in security and privacy audits and help address any identified issues.

• High school diploma or GED and additional relevant experience required; Bachelor's degree preferred.
• Minimum of 5 years of medical device Regulatory Affairs experience required, with international experience preferred.
• Thorough understanding of ISO 13485.
• Working knowledge of ISO 14971 and IEC 62304 preferred.
• Experience working with domestic and international regulatory agencies (MDSAP regions preferred).
• Experience working with technical documentation in support of EU MDR medical device CE marking.
• Demonstrated success in managing structured regulatory submission activities.
• Thorough knowledge of design controls.
• Technical knowledge of software-driven electro-mechanical medical devices preferred.
• Ability to assist and advise on regulatory-based decisions.
• Methodical with attention to detail and good organizational skills.
• Ability to prioritize multiple projects and tasks.
• Clear communication skills, both written and verbal, at all levels within and outside the organization.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
• Willingness to travel domestically and internationally, up to 10%.

Please review our benefits here: Life at OSI
The specific programs and options available to any given employee may vary depending on eligibility factors such as geographic location and date of hire. Please note that the salary information shown above is a general guideline only. Salaries are based upon candidate experience and qualifications, as well as market and business considerations.

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

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Poster Link: https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf

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.