Regulatory Affairs Associate II

10 hours ago

Birmingham, United States BIOHORIZONS IMPLANT SYSTEMS Full time
Job DescriptionJob Description


The Regulatory Affairs Associate II will assist with the companies compliance with product registration requirements in international markets as well as compliance with Quality Systems regulations, standards, Good Manufacturing Practice and Good Documentation Practice. The ideal candidate must live in Birmingham, Al.

The responsibilities of this position include, but may not be limited to the following:

  • Adhere to the company’s Quality Management System to ensure compliance with applicable regulatory requirements
  • Maintain Company product registrations on a global basis, in compliance with U.S. FDA, EU MDD 93/42/EEC, Health Canada CMDR and other international regulations
  • Maintenance of Company product registrations data for all global markets
  • Assist other Regulatory Affairs personnel with international market regulatory activities as directed
  • Research and report on adverse event reporting requirements, field correction notification requirements, market clearance requirements, etc
  • Manage multiple establishment and product registration projects efficiently, effectively and concurrently
  • Interact with multiple internal departments as well as international customers and regulators to complete assigned responsibilities

The ideal candidate for this position will possess the following qualifications:

  • Bachelor’s Degree required, preferably in a STEM program
  • Master’s Degree preferred
  • 3+ years’ experience in a U.S. FDA-regulated and registered medical device Manufacturer or Specification Developer environment in U.S. and foreign regulatory submissions required
  • Experience with 510(k) FDA submissions preferred
  • Complaints Management, MDR Reporting, CAPA administration, Auditing experience preferred
  • U.S. RAPS Regulatory Affairs Certification preferred
  • ASQ certification in Quality Manager, Engineer, or Auditor desired
  • Strong attention to detail required
  • Excellent organizational, interpersonal, written, and verbal skills
  • Demonstrated problem-solving skills
  • Must have the ability to work and communicate effectively with others
  • Experience with MS Office suite required

Benefits:

  • 2 comprehensive medical plan options to choose from available the first of each month following your date of hire
  • Flexible Spending Account or HSA Account available
  • Vision Benefits
  • Company paid Dental Insurance for employee and dependents
  • Wellness Plan
  • 401k with 5% matching
  • Generous PTO plan including 11 paid holidays, 2 Floating Holidays and Community Service Hours
  • Company paid Short Term Disability
  • Long Term Disability
  • Company provided Life Insurance
  • Paid Parental Leave
  • Casual Dress Code
  • Social events for employees and family

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Please note that any offer of employment made by BioHorizons is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen.

  • Regulatory Affairs Associate I

    11 hours ago

    Birmingham, United States BIOHORIZONS IMPLANT SYSTEMS Full time

    Job DescriptionJob DescriptionThe Regulatory Affairs Associate I can heavily influence the company's compliance with various initial and renewal registrations with state Boards of Pharmacy and tissue banking regulators, and various federal medical device and tissue banking establishment registrations The RA department's is also responsible for...

  • Quality Assurance Associate II

    1 month ago

    Birmingham, Alabama, United States American Red Cross Full time

    Quality Assurance RoleWe are seeking a Quality Assurance Associate II to join our team at the American Red Cross. As a Quality Assurance Associate II, you will be responsible for reviewing, assessing, and monitoring records, processes, and systems at critical control points in the process.ResponsibilitiesReview and assess records, processes, and systems to...

  • Neurophysiology Technologist II EEG

    1 month ago

    Birmingham, United States Children's of Alabama Full time

    Job Summary Neurophysiology Technologist II is a mid-level position in the Neurophysiology Department. The Neurophysiology Technologist II performs EEGs, LTVM EEGs, and Ambulatory EEGs in the Neurophysiology Department per department policies and procedures. The Neurophysiology Technologist II must be able to use the 10/20 and 10/10 systems for EEG...

  • HVAC Service Technician II

    4 weeks ago

    Birmingham, Alabama, United States Daikin Applied Full time

    Job SummaryDaikin Applied is seeking a skilled HVAC Service Technician II to join our team. As a key member of our service team, you will be responsible for diagnosing, repairing, and performing preventative maintenance of commercial and industrial HVAC equipment.Key ResponsibilitiesPerform maintenance of HVAC unitary and applied equipment, including logging...

  • Compliance Associate II

    2 weeks ago

    Birmingham, United States Advanced Diabetes Supply Full time

    Job DescriptionJob DescriptionDescription:About Our CompanyAdvanced Diabetes Supply® was founded on the bold principle of creating a knowledgeable, reliable and demonstrably superior diabetes supply company. Our approach, coupled with a commitment to service and innovation, has catapulted Advanced Diabetes Supply® to a national leader in the industry....

  • Clinical Nurse

    4 weeks ago

    Birmingham, Alabama, United States WellStar Health System Full time

    Job Summary:The Clinical Nurse II is a key member of the interdisciplinary team at WellStar Health System, providing high-quality patient care and promoting a positive patient experience. This role requires a proactive and collaborative approach, working closely with other healthcare professionals to ensure seamless care delivery.Core Responsibilities:1....

  • Cook II

    19 hours ago

    Birmingham, United States Marriott International, Inc Full time

    Additional InformationJob Number24171638Job CategoryFood and Beverage & CulinaryLocationSheraton Birmingham Hotel, 2101 Richard Arrington Jr Blvd N, Birmingham, Alabama, United States, 35203VIEW ON MAPScheduleFull TimeLocated Remotely?NPosition Type Non-Management POSITION SUMMARY Prepare ingredients for cooking, including portioning, chopping, and storing...

  • Cook II

    5 days ago

    Birmingham, United States Marriott International, Inc Full time

    Additional InformationJob Number24171638Job CategoryFood and Beverage & CulinaryLocationSheraton Birmingham Hotel, 2101 Richard Arrington Jr Blvd N, Birmingham, Alabama, United States, 35203VIEW ON MAPScheduleFull TimeLocated Remotely?NPosition Type Non-Management POSITION SUMMARY Prepare ingredients for cooking, including portioning, chopping, and storing...

  • Clinical Research Associate

    6 months ago

    Birmingham, United States Parexel Full time

    When our values align, there's no limit to what we can achieve.   Working with heart At the end of the day we’re all patients. Because of this, the Parexel team takes our work personally and does it with empathy and heart. When our values align, there’s no limit to what we can achieve. Our clinical operating model drives effectiveness, reduces...

  • Biomedical Technician

    2 weeks ago

    Birmingham, United States TRIMEDX Full time

    If you are wondering what makes TRIMEDX different, it‘s that all of our associates share in a common purpose of serving clients, patients, communities, and each other with equal measures of care and performance.Everyone is focused on serving the customer and we do that by collaborating and supporting each otherAssociates look forward to coming to work each...

  • Data Analytics Analyst II

    2 weeks ago

    Birmingham, United States Alliance of Professionals & Consultants, Inc. Full time

    Job Title: Data Analytics Analyst IIType of Engagement: 6-month contract (Not open to 3rd party C2C consultants. Visa sponsorship is not available)Work Location: Hybrid in Birmingham, ALCandidates must reside in the Birmingham, AL area. Required Skills & Experience: 3-5 Years Proficient in using tools like Python, R, SQL, and data visualization libraries...

  • Engineering Technician II

    1 month ago

    Birmingham, AL, USA, United States Terracon Full time

    About the RoleTerracon is seeking a highly skilled Engineering Technician II to join our team in Birmingham, AL. As a key member of our Materials team, you will be responsible for performing field and laboratory testing, observation, and inspection of construction materials.Key ResponsibilitiesConduct field and laboratory testing, observation, and inspection...

  • Clinical Research Associate

    1 month ago

    Birmingham, Alabama, United States No-Resistance Consulting Group Full time

    Job OverviewNo Resistance Consulting Group is seeking a highly motivated and detail-oriented Clinical Research Associate to join our team. In this role, you will play a crucial part in the implementation and execution of clinical research projects, ensuring the successful attainment of quality, safety, regulatory, and financial objectives.Key...

  • Accounting Associate

    4 weeks ago

    Birmingham, Alabama, United States Altec Industries Full time

    Job SummaryAltec Industries is seeking an experienced Accounting Associate to join our team. As an Accounting Associate, you will be responsible for performing a variety of accounting and financial tasks, including data entry, processing payments, and creating and reviewing monthly statements.ResponsibilitiesHigh volume data entry and processing payments for...

  • Diesel Technician/Mechanic II

    3 weeks ago

    Birmingham, United States Penske Truck Leasing Full time

    What’s the Job? Ready to move your career forward? As a Technician at Penske, you’ll do exactly that. Here, you’ll perform preventative maintenance and repairs of all levels on the newest and best maintained fleet of vehicles in the industry. You will help our customers keep their vehicles in shape and on the road. As a Technician II at...

  • Diesel Technician/Mechanic II

    4 weeks ago

    BIRMINGHAM, United States Penske Truck Leasing Full time

    What’s the Job? Ready to move your career forward? As a Technician at Penske, you’ll do exactly that. Here, you’ll perform preventative maintenance and repairs of all levels on the newest and best maintained fleet of vehicles in the industry. You will help our customers keep their vehicles in shape and on the road. As a...

  • Diesel Technician/Mechanic II

    3 weeks ago

    BIRMINGHAM, United States Penske Truck Leasing Full time

    What’s the Job? Ready to move your career forward? As a Technician at Penske, you’ll do exactly that. Here, you’ll perform preventative maintenance and repairs of all levels on the newest and best maintained fleet of vehicles in the industry. You will help our customers keep their vehicles in shape and on the road. As a Technician II at...

  • Diesel Technician/Mechanic II

    3 weeks ago

    BIRMINGHAM, United States Penske Truck Leasing Full time

    What’s the Job? Ready to move your career forward? As a Technician at Penske, you’ll do exactly that. Here, you’ll perform preventative maintenance and repairs of all levels on the newest and best maintained fleet of vehicles in the industry. You will help our customers keep their vehicles in shape and on the road. As a...

  • Diesel Technician/Mechanic II

    4 weeks ago

    BIRMINGHAM, United States Penske Truck Leasing Full time

    What’s the Job? Ready to move your career forward? As a Technician at Penske, you’ll do exactly that. Here, you’ll perform preventative maintenance and repairs of all levels on the newest and best maintained fleet of vehicles in the industry. You will help our customers keep their vehicles in shape and on the road. As a...

  • Diesel Technician/Mechanic II

    4 weeks ago

    BIRMINGHAM, United States Penske Truck Leasing Full time

    What’s the Job? Ready to move your career forward? As a Technician at Penske, you’ll do exactly that. Here, you’ll perform preventative maintenance and repairs of all levels on the newest and best maintained fleet of vehicles in the industry. You will help our customers keep their vehicles in shape and on the road. As a...