Current jobs related to Global Regulatory Affairs Specialist - Grand Rapids - SunMed LLC

  • Senior Regulatory Compliance Specialist

    1 week ago

    Grand Rapids, Minnesota, United States Robertshaw Full time

    Job Summary:Robertshaw is a global leader in design, engineering, and manufacturing of product solutions for the appliance, automotive, and HVAC industries. We are seeking a highly experienced Senior Regulatory Compliance Specialist to lead our safety approval programs and ensure compliance with certifying bodies' requirements.Key Responsibilities:Analyze...

  • Global Talent Acquisition Specialist

    2 weeks ago

    Grand Rapids, Michigan, United States CURE International Children's Hospitals Full time

    Job Title: Global Talent Acquisition SpecialistCURE International Children's Hospitals is seeking a highly skilled Global Talent Acquisition Specialist to join our team. As a key member of our recruitment team, you will be responsible for driving the full life cycle of recruitment, selection, and onboarding for positions hired by the CURE Corporate...

  • Global Health Programs Specialist

    1 week ago

    Grand Rapids, Minnesota, United States American Academy Of Pediatrics Full time

    The American Academy of Pediatrics is seeking a highly skilled public health professional to join our global health team as a Global Health Programs Specialist.This role will provide administrative and programmatic support to our global health staff, including providing technical assistance and support to newborn and child health programs.The successful...

  • Automotive Inventory Specialist

    7 days ago

    Grand Rapids, Michigan, United States Global Staffing Service's Full time

    Job Title: Automotive Inventory SpecialistJob Description:Are you looking for a challenging and rewarding career in inventory management? Do you have a passion for automotive industry and a knack for detail? We are seeking an experienced Automotive Inventory Specialist to join our team at Global Staffing Services.As an Automotive Inventory Specialist, you...

  • Paralegal Specialist

    1 week ago

    Grand Rapids, Michigan, United States SGI Global, LLC Full time

    Job Title: Paralegal SpecialistSGI Global, LLC is seeking a highly skilled Paralegal Specialist to support the U.S. Attorney's Office (USAO) Western District of Michigan. The successful candidate will perform a variety of litigation support services in support of the investigation and prosecution of cases under the USAO's Affirmative Civil Enforcement...

  • Compliance and Legal Affairs Director

    4 weeks ago

    Grand Junction, Colorado, United States Community Hospital, Grand Junction, Colorado Full time

    Job Title: Vice President of Compliance and Legal AffairsCommunity Hospital, Grand Junction, Colorado seeks a highly skilled and experienced Vice President of Compliance and Legal Affairs to lead all aspects of legal and regulatory compliance. This key role will ensure the organization's adherence to federal, state, and local regulations, as well as internal...

  • Medical Imaging Specialist

    7 days ago

    Grand Rapids, Michigan, United States PSG Global Solutions Careers Full time

    We're seeking a skilled Radiology Technologist to join our team at PSG Global Solutions Careers. As a Medical Imaging Specialist, you'll work in a dynamic environment, utilizing your expertise in ultrasound technology to capture high-quality images.Key Responsibilities:Adjusting equipment to ensure optimal image qualityCalming patients to eliminate test...

  • Director of Legal Affairs

    4 months ago

    Grand Rapids, United States Haworth, Inc. Full time

    Why Haworth? When you feel connected to your work, you feel more engaged. At Haworth, you can pursue a career that offers you ample opportunity to build your portfolio and expand your skillset in an exciting and inclusive environment. Join a company that values innovation, inspiration, and you! HAWORTH is a global leader in office furniture and architectural...

  • Director of Legal Affairs

    4 months ago

    Grand Rapids, United States Haworth, Inc. Full time

    Why Haworth? When you feel connected to your work, you feel more engaged. At Haworth, you can pursue a career that offers you ample opportunity to build your portfolio and expand your skillset in an exciting and inclusive environment. Join a company that values innovation, inspiration, and you! HAWORTH is a global leader in office furniture and architectural...

  • Quality Management Systems Specialist

    2 weeks ago

    Grand Rapids, Michigan, United States Oliver Healthcare Packaging Full time

    Job Title: Quality System SpecialistOliver Healthcare Packaging is seeking a highly skilled Quality System Specialist to oversee the implementation and maintenance of our Quality Management Systems.Key Responsibilities:Administer the internal audit system, creating annual schedules and participating in audits to ensure compliance with written...

  • Labeling Specialist, Grand Rapids MI

    4 weeks ago

    Grand Rapids, United States SunMed Group Holdings, LLC dba AirLife Full time

    Job DescriptionJob DescriptionCOMPANY DESCRIPTIONAt AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing...

  • Compliance Analyst

    2 weeks ago

    Cedar Rapids, Iowa, United States TEPHRA Full time

    Job Title: Compliance Analyst - Consumer Complaints SpecialistAt Tephra, we are seeking a highly skilled Compliance Analyst - Consumer Complaints Specialist to join our team. This role is responsible for managing all aspects of consumer complaint handling, ensuring compliance with regulatory and legal requirements.Key Responsibilities:Manage the intake,...

  • Plasma Center Paramedic Specialist

    2 weeks ago

    Grand Rapids, Michigan, United States Biolife Plasma Services Full time

    About the RoleWe are seeking a highly skilled Paramedic to join our team at BioLife Plasma Services. As a Paramedic, you will play a critical role in supporting plasma center operations and ensuring the highest level of customer service and quality.Key ResponsibilitiesDetermine donor eligibility to donate plasma, including proper management of informed...

  • Mechanical Reliability Specialist

    4 weeks ago

    Wisconsin Rapids, Wisconsin, United States Sonatec Global Recruitment Full time

    Job Opportunity: Mechanical Reliability EngineerSonatec Global Recruitment is proud to partner with a world-leading FMCG business to recruit a Mechanical Reliability Engineer for a challenging and rewarding role located in the UK.As a key member of the team, you will be responsible for developing and implementing maintenance and technical skills across shift...

  • Radiation Oncology Specialist

    3 weeks ago

    Grand Rapids, Michigan, United States Bamf Health Full time

    About the RoleBAMF Health is seeking a highly skilled Radiation Oncology Specialist to join our team. As a key member of our global team, you will contribute to pioneering technology and deliver top-tier patient care.Key ResponsibilitiesEvaluate and manage oncology patients with the highest level of carePrescribe and supervise Radiopharmaceutical Therapy...

  • Compliance Analyst

    3 weeks ago

    Cedar Rapids, Iowa, United States TEPHRA Full time

    Job SummaryThe Compliance Analyst - Consumer Complaints Specialist is responsible for managing all aspects of consumer complaint handling, ensuring compliance with regulatory and legal requirements. This role involves resolving complex operational and compliance issues, ensuring adherence to compliance procedures and protocols.Key ResponsibilitiesManage the...

  • Plasma Center Nurse Specialist

    2 weeks ago

    Grand Rapids, Michigan, United States Biolife Plasma Services Full time

    About the RoleWe are seeking a highly skilled and compassionate Medical Support Specialist to join our team at BioLife Plasma Services. As a key member of our plasma collection operations, you will play a vital role in ensuring the highest quality plasma is collected and processed for life-changing medicines.Key ResponsibilitiesDetermine donor eligibility to...

  • Plasma Center Nurse RN

    2 weeks ago

    Grand Rapids, United States Biolife Plasma Services Full time

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.**Job...

  • Global Process Owner Core Design Processes Specialist

    2 weeks ago

    Grand Rapids, Michigan, United States Kion Group AG Full time

    Job Summary:Kion Group AG is a leading global intralogistics provider with two main business segments: Industrial Trucks & Services (ITS) and Supply Chain Solutions (SCS). The company's Business Transformation (BT) initiative aims to harmonize all business processes, data objects, and IT systems across the organization. The Design-to-Build process area...

  • Donor Intake Nurse

    3 hours ago

    Grand Rapids, United States BioLife Plasma Services Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my...

Global Regulatory Affairs Specialist

2 months ago

Grand Rapids, United States SunMed LLC Full time
Job DescriptionJob Description


COMPANY DESCRIPTION

At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing consumables. This growth philosophy has positioned us to increase our global footprint and business reach, impacting even more people around the world. Our expanding family of the most trusted brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind. Collective expertise allows us to provide quality products and experiences to our patients, customers, and our people. Our values of Customer first, Differentiate with our People, Bias for Action, Continuous Improvement and Accountability define who we are and how we work. Join us

POSITION SUMMARY

The Global Regulatory Affairs Specialist is responsible for establishing and sustaining the global device registrations and licenses for the organization. This position will partner with the International Sales team to service customer needs.

The Global Regulatory Affairs Specialist will support our efforts to ensure compliance with global market requirements. This position will be responsible for gathering and establishing documentation relevant to international registrations and licenses and daily business needs. This includes, but is not limited to, MDSAP (US, Canada, Brazil, Australia, and Japan) and EU requirements.

Another responsibility of this role is to represent the Regulatory Affairs department in corporate projects. They will perform regulatory impact assessments and support the deliverables from those assessments.

POSITION QUALIFICATIONS

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.

Knowledge:

Acquired through education, certifications, training, and experience.

  • Work in an FDA-regulated industry.
  • Experience with product requirements, US, Canada, EU and other major international markets.
  • Knowledge of quality and product standards for medical devices (e.g. ISO 13485, ISO 14971, FDA QSR, EU MDD/MDR, and Canadian MDR)

Skills & Abilities:

  • Excellent technical writing skills.
  • Excellent verbal and written communication skills.
  • Excellent organizational skills and attention to detail.
  • Ability to multi-task.
  • Strong adaptability and active learning to keep pace with evolving International regulatory needs.
  • Excellent time management.
  • Strong computer skills: MS Word, MS Excel (chart, pivot tables), PowerPoint, and database management.
  • Attention to detail.
  • Analytical skills.

Level of Experience: 2+ years of experience in medical device. 2+ years of experience in regulatory affairs.

Level of Education: Bachelor’s degree in Biological Sciences, Biochemistry, Chemistry, Toxicology, Pharmacy, Medicine, Engineering, or another similarly technical field.

Travel: 10%

ESSENTIAL DUTIES AND RESPONSIBILITIES

The core tasks, duties, and responsibilities that must be performed on the job.

  • The International Regulatory Specialist is responsible for establishing and maintaining our global registrations and licenses.
  • Organize and track Airlife’s existing global registrations.
  • Work closely with the International Sales team to grow our global footprint.
  • Coordinate efforts associated with the preparation of regulatory documents and submissions for international registrations.
  • Communicate with foreign distributors and regulatory agencies regarding pre-submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Participate in internal and external audits as it relates to global registrations, licensing, and requirements.
  • Recommend updates to technical documentation and associated procedures in response to changes in international regulations or standards.

OTHER RESPONSIBILITIES

  • Focus on achieving our Company mission.
  • Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
  • Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
  • Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
  • Contribute to building and maintaining a positive team environment.
  • Assure all policies and guidelines are implemented and followed.

QUALITY POLICY

At AirLife, Quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

DEIA STATEMENT
At AirLife, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve. We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.