Sr. Regulatory Affairs Specialist - REMOTE

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 Senior Regulatory Affairs (RA) Specialist supports the regulatory and product registration activities of the company.  This RA Specialist role requires a professional who will work closely with high priority regulatory activities such as U.S. premarket submissions, product registration in MDSAP countries, and other primary international market registrations.  You will provide regulatory feedback in order to facilitate the launch of new products globally and work with the design control teams to assess for regulatory impact of product changes. You will provide technical guidance to cross functional teams for submission preparation and interaction with regulatory agencies.

• Coordinate, author, and prepare regulatory submissions, including 510(k) premarket notifications, Canadian license applications, international submission packages and/or other documentation required for worldwide registration/licensure of products.
• Work as a strategic business partner with business clients to proactively develop and implement practical, compliant regulatory plans, and also timely, effective business solutions to quality and regulatory issues.
• Respond to regulatory agency requests and obtain necessary premarket clearances and/or approvals from domestic and international regulatory agencies.
• Provide general support to the RA/QA department in regulatory-related matters.
• Communicate with external agencies including the US FDA, Health Canada, and other health authorities with which the department interacts.
• Act as regulatory SME in product development cross-functional teams and other cross-functional activities as assigned.
• Evaluate and approve proposed changes to products and controlled documents; develop, approve, and implement global regulatory action plans based on these changes.
• Maintain regulatory information in Rimsys, regulatory information management system, to ensure product selling status is in regulatory compliance with applicable local and regional country requirements.
• Review and approve labeling for compliance to standards, guidelines, regulations, and regulatory approvals/clearances.
• Provide assistance and expertise during regulatory inspections or audits.
• Create and maintain regulatory documents and records, including summaries of such regulatory affairs activities and reports to management.
• Continue to enhance internal regulatory procedures and processes.  Create and revise procedures as needed and provide training for these updates.
• This position requires the ability to take initiative and effectively communicate cross-functionally, both externally and at all levels of the organization.
• 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 the recurrence of the problem.
• Duties may be modified or assigned at any time to meet the needs of the business.
• Recommend and maintain quality programs and systems to support corporate quality policy, regulatory requirements, and quality objectives.

• Bachelor’s Degree is required.  A degree with technical / engineering background is preferred.
• A minimum of 8 years in medical device or related field and 5 years of Regulatory Affairs experience is required. Experience with SaMD is preferred.
• Experience working with regulatory agencies is required, preferably FDA experience and/or their global counterparts.
• Demonstrated success in management of regulatory submissions activities.
• Strong technical knowledge of medical products.
• Thorough knowledge of product development process and design control.
• Ability to assist and advise with regulatory decisions.
• Methodical with attention to detail and good organizational skills.
• The ability to work and prioritize multiple projects and tasks.
• The ability to communicate clearly in writing and verbally at all levels and with all departments within and outside of the organization.
• Ability to work proficiently with Microsoft Word, Excel, PowerPoint, Teams & Outlook is required.
• Working knowledge of PLM software preferred.
• Some travel, domestic and/or international, up to 10%.

#LI-Remote

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 - Disability and Veterans

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Poster Link: https://www.eeoc.gov/sites/default/files/migrated_files/employers/eeoc_self_print_poster.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.