Regulatory Affairs Specialist
Company : Spacelabs
Country: United States
Location : Snoqualmie, Washington
Post: Sat, 30 Jul 2022 21:27:09 GMT
Expires: Sat, 27 Aug 2022 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
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 supports the regulatory compliance and registration activities of the company. This role within Regulatory Affairs will provide dedicated and on-going technical and administrative support for global registration and compliance efforts. With guidance from the regulatory senior staff and management team, this position will work with cross functional teams to develop and execute regulatory strategies for new product development, market introductions and compliance efforts. The Regulatory Affairs Specialist will work closely with global partners including license holders and distributors and prepare registration and compliance efforts.
Work with global partners and support worldwide new registrations efforts.
Work with Regulatory Senior Leadership to support US submissions through, 510k, PMA.
Develop EU technical files and communicate with Notified Body.
Communicate changes to global regulatory authorities.
Complete new product registrations by supporting in-country representation.
Embed within product design teams to act as regulatory representation and advise on documentation and regulatory strategy.
Assist with Regulatory Intelligence process.Keep current and inform other members of the regulatory team on changes to worldwide medical device regulations, product registration requirements, and standards.
Assess the impact of changes in regulations, requirements, and standards to Spacelabs products and systems globally.
Gather and present regulatory performance metrics on a regular and timely basis.
Continue to enhance the regulatory processes and procedures; create and revise work instructions and training as needed for these updates.
Assist the Regulatory Affairs Specialists as needed.Maintain a system to assure that all state product registrations are maintained and renewed in a timely manner.
Coordinate, prepare and obtain necessary information for moderately complex regulatory submissions, domestic and internationally.
Provide input on, review and approve product and labeling changes for compliance to standards, guidelines, regulations, and regulatory approvals/clearances.
Provide general support to the regulatory department in all regulatory-related matters and requests, such as requests for CFG, document legalization/apostil.
Provide assistance and expertise during regulatory inspections or audits.
Support and assist Recall / Field Corrective Action process.
Communicate with customers on sensitive regulatory matters.
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.
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 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.
A Bachelor’s Degree is required or equivalent applicable work experience.
A minimum of 2 years of medical device regulatory industry experience is required, international regulatory experience preferred.
Experience working with distributors or regulatory agencies.
Demonstrated research and analytical skills.
Understanding of FDA 510k.
General understanding 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.
Current working knowledge of Microsoft Word, Excel, PowerPoint & Outlook.
Meeting at off business hours is required at times to support global registration (e.g., evening meetings with APAC).
Some travel, domestic and international, up to 10%.
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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