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Director Global Regulatory Affairs
Why work at Spacelabs? Because lives depend on you!
Spacelabs Healthcare, one of the world’s most respected medical device manufacturers, is seeking an experienced regulatory leader to join our team in Snoqualmie, Washington. The Director of Global Regulatory Affairs is a highly motivated, technically savvy, team builder who enjoys a fast-paced work environment, the freedom to establish a strategic vision and then execute on it and will obtain tangible results in a short period of time. A proven track record of success in directing the regulatory process for US Class II / EU Class IIb products requiring governmental approval by ensuring that all necessary applications and adverse event reports are filed, and procedures are developed to ensure regulatory compliance. Responsibilities include managing the planning and implementation of the Spacelabs Healthcare regulatory affairs activities for Diagnostic Cardiology (DC) and Patient Monitoring and Connectivity (PM&C) devices, the creation and implementation of corporate regulatory processes, process maps, procedures and tools, and adverse event reporting.
- Work with other departments and QA Directors within Spacelabs Healthcare to develop and deploy policies/processes in compliance with global regulations and corporate guidelines.
- Provide hands on project management of regulatory activities.
- Develop capital, operating, staffing, and project budgets; establish annual department operating objectives and plans; and make staffing and compensation decisions.
- Ensure that regulatory affairs professionals are fully competent for their roles, that they are effectively organized to deliver service to users, and that they receive appropriate training and mentoring.
- Monitor regulatory and technology trends such as updates to medical device regulations, emerging medical device standards and new regulatory approach to Innovative product opportunities (“Regulatory Intelligence”).
- Manage a team to execute pre-approval compliance activities:
- Provide input and compliance oversight to R&D and New Product Development process to ensure relevant regulatory requirements are identified and delivered on time and on budget.
- Recommend and implement corporate global regulatory strategy.
- Monitor impact of changing regulations on submission strategies and update internal stakeholders.
- Represent Spacelabs Healthcare and actively participate in Standards Committee’s and industry working groups. Monitor and communicate changes to standards to ensure Spacelabs Healthcare is aware of any new standards and regulatory activity that could impact our business.
- Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
- Provide strategic input and technical guidance to software architects, system engineering, and product management on regulatory requirements of system architecture, advanced workflow, and federated data models to ensure continuous data delivery globally.
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval. Build positive relationships with reviewers.
- Manage a team to execute post-market compliance activities:
- Provide oversight of Health Hazard Evaluation and Recall initiation process.
- Ensure all Adverse Events are adequately investigated and reported on time globally.
- Maintain Clinical Evaluation and Post Market Surveillance Reports.
- Maintain product registrations and re-registrations globally. Oversee Distributor Registrations.
- Support the company legal department in correspondence, investigations, and any other regulatory activity as it relates to the company products and services.
- Select, implement, create and execute training, and manage corporate regulatory tools.
- Assist in regulatory due diligence and acquisition transfer activities.
- Assign and manage regulatory agency representatives like Official Correspondent, U.S. Agent, and Authorized EC Representative.
- Works as a strategic business partner with business clients to proactively and reactively develop and implement practical, timely, and effective business solutions to quality and regulatory issues.
- Uphold Spacelabs values of Customer Obsession, Ownership Mindset and Superior Results.
- Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. 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 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.
- Ensure that direct report(s) are trained and evaluated on their knowledge and adherence to the company’s values, Code of Ethics and Conduct, and applicable compliance policies.
- Bachelor’s degree required, preferably in computer science, engineering, or regulatory affairs. Master’s degree or MBA is highly preferred. Regulatory or industry certification is highly desirable.
- 10+ years medical device regulatory and quality systems experience or equivalent.
- 10+ years quality leadership experience with a demonstrated ability to lead and manage people and teams.
Desired Competencies, Skill and Abilities
- Expert knowledge of data models, informatics, and cloud technology regulatory compliance.
- Creative problem solving, flexibility, and good negotiation skills are a must. Proven ability to drive results to schedule and budget.
- Proven ability to communicate effectively both in writing and verbally with staff at all levels of the organization.
- Technical writing and presentation skills required. Proficiency with Microsoft Word, PowerPoint and Excel required.
- Proven track record of successful interactions with regulatory agencies resulting in successful approval / clearance of Cloud based and Software as a Service Medical Device in EU, US, Canada, LATAM, and APAC.
- Must be knowledgeable of FDA Design Control requirements.
- Must have experience working with OEM vendors and Distributors.
- Must have experience managing remote business activities.
- Must be comfortable and effective acting as a catalyst for change.
- Proven track record managing global software product registrations to include Japan, China, Brazil, Mexico, Russia, and Europe.
- Great leadership skills, more specifically in influencing, and driving complex situations and projects to the desired outcome.
- Good understanding of multiple functions with the ability to be a bridge for problem-solving between several functions across the company.
- High degree of creativity and problem-solving ability to adapt existing tools and customize new ones to suit Spacelabs Healthcare’s needs.
- Hard driver; high energy; positive attitude; works well under stress and with ambiguity.
- Uphold the Company’s core values of Relentless Customer Focus, Ownership and Accountability, Teamwork with Trust, Always Learning and Applying, Act with Integrity, Nimble Innovation.
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.
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Job posted: 2022-01-03