Director Global Regulatory Affairs

09 Nov, 2022

Jobs

Director Global Regulatory Affairs

Spacelabs Healthcare
Snoqualmie, WA

Job Description

OverviewAt 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 Director of Global Regulatory Affairs is a highly motivated, technically savvy, team builder who ensures that Spacelabs complies with all foreign and domestic government regulations, product and quality management system standards, and internal controls. The Director of Global of Regulatory Affairs develops processes, procedures, and systems to ensure that all products are designed, development, manufactured, sold, and distributed in compliance with all applicable laws and regulations. He or she facilitates all licenses, filings, certifications, and mandatory reporting required for the company’s medical device products.

Responsibilities

  • Work with other departments and management within Spacelabs Healthcare to develop and deploy policies/processes in compliance with global regulations and corporate guidelines.
  • 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.
  • 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.
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval. Build positive relationships with reviewers.
  • 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”).
  • Prepare regulatory submissions to secure all necessary medical devices licenses and registrations for distribution and marketing in the United States, CE Marking under the European Medical Device Regulations, and all intended Rest of World target markets.
  • Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
  • Monitor the impact of changing regulations and update internal stakeholders, conduct gap analysis, prepare action plans, and ensure timely compliance.
  • Represent Spacelabs Healthcare and actively participate in Standards Committee’s and industry working groups.
  • Facilitate Health Hazard Evaluation and Field Corrective Action processes.
  • Ensure all Adverse Events are adequately investigated and reported in a timely manner.
  • Complete Post Market Surveillance analyses and reports, including design control change assessments and defect analysis.
  • Maintain Clinical Evaluation Reports and Post Market Clinical Follow-up.
  • 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 Correspondents, U.S. Agents, and Authorized Representatives.
  • 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 the Company’s core values of Relentless Customer Focus, Ownership and Accountability, Teamwork with Trust, Always Learning and Applying, Act with Integrity, Nimble Innovation.
  • 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.

Qualifications

  • Bachelor’s degree required, preferably in computer science, engineering, or regulatory affairs. Master’s degree in Regulatory Affairs, Quality Assurance, 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.
  • 5+ years of medical device domestic and foreign submissions, licensing, and registration.

 Desired Competencies, Skill and Abilities

  • Proven track record managing medical device and software product registrations in the US, the Americas, Europe, Asia, Middle East, and Australia.
  • 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.
  • Experience and US and EC Class I and II devices.
  • Technical writing and presentation skills required.  Proficiency with Microsoft Word, PowerPoint and Excel required.
  • 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.
  • Great leadership skills, more specifically in influencing, and driving complex situations and projects to the desired outcome.
  • High degree of creativity and problem-solving ability to adapt existing tools and customize new ones to suit Spacelabs Healthcare’s needs.
  • 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.
  • 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

 

EEO is the Law

 

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.

Learn more here

Job posted: 2022-11-09