Meridian Bioscience

Senior Regulatory Affairs Specialist

Job Locations US-MA-North Billerica
Company
Meridian Bioscience, Inc.
Department
Quality & Regulatory Affairs
# of Openings
1

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job Summary

JOB SUMMARY:

The Regulatory Affairs Senior Specialist will be responsible for supporting Meridian's pre- and post-market regulatory and quality processes, including Magellan's product realization process, to ensure that Magellan’s activities are consistent with applicable quality and regulatory requirements throughout all stages of the product lifecycle, including research, design, development, transfer, manufacturing, validation/verification, labeling, regulatory submissions, lifecycle maintenance, MDR and Vigilance reporting, product certifications and registrations, and technical files development and maintanance.  The RA Sr. Specialist will work with cross-functional teams on-site and across parent company Meridian Bioscience’s global sites to ensure that regulatory guidance is provided in support of local and global business objectives.

Key Duties

KEY DUTIES:

  • Supports and authors regulatory submissions for domestic, world-wide commercialization, and other business objectives.
  • Drafts, evaluates, and reviews technical protocols, reports, and data in support of clinical trials, validation, verification, and product development and manufacturing.
  • Provides support and guidance to quality and regulatory activities, including Design Control activities, project teams, design transfer activities, clinical trials, validation and verification activities, and existing product modifications.
  • Provides direct support associated with adverse events, medical device reportable events, vigilance reporting, advisory notices, and product recall activities, including corrections and removals, and stock rotations.
  • Evaluates the regulatory impact of changes associated with product design change and routine change control.
  • Drafts, reviews, and helps provide guidance for product labeling activities, including Instructions for Use (IFU/PI), to ensure adherence to applicable regulations and standards.
  • Provides regulatory input and oversight to product lifecycle planning, including risk management activities
  • Monitors product lifecycle and compiles information associated with changes as directed.
  • Compiles new product technical information and feature summaries in support of market expansion.
  • Responds to Sales & Marketing requests to ensure content of collateral and promotional materials is compliant with applicable regulations.
  • Participates in long-term projects supporting the business, and quality and regulatory objectives of the local and global organization.
  • Suppotrs Post Market Vigilance (PMV) team and has responsibility for regulatory aspects of PMS (Post Market Surveillance)
  • Contributor to Management Review
  • Supports third party and internal Quality Audit programs; ability to perform internal and supplier audit and verification activities is an added plus.
  • Other duties as assigned.

Qualifications

QUALIFICATIONS:

Education/Experience:

  • BS in Biological Science, Microbiology, Chemistry, Chemical Engineering, or equivalent.
  • MS Regulatory affairs, RAC both highly desirable
  • A minimum of 3-5+ years experience in an FDA/ISO regulated industry: Quality Assurance, Quality Systems, Design Control, Regulatory Affairs, or equivalent.
  • A minimum of 2 years of direct Regulatory Affairs experience is required, including preparation of Pre-IDEs, 510(k) applications and amendments, Letters to File, EU Technical Files, Canadian Class II and III licenses, STED documentation, etc.; Special 510(k), DeNovo, and PMA/PMAS submissions a plus.
  • Experience with Post Market Surveillance
  • Development and design controls of In Vitro Diagnostics or Medical Devices is a must.
  • Proven knowledge of FDA and ISO regulated environment of Medical Devices or In Vitro Diagnostics (preferred), including risk management principles (i.e., ISO 14971).
  • Experience with Health Canada is highly desirable, TGA, ANVISA, and Japan’s PMDA and MHLW is desirable.

 

Skills, Specialized Knowledge and Abilities:

  • Self-Starter, able to plan and complete timelines and tasks independently to achieve given goals and objectives.
  • Demonstrated strong leadership, project management, and organizational skills.
  • Highly motivated, detail oriented, must have a constant awareness of customer requirements and must demonstrate an ability to make fact-driven decisions.
  • Maintain accurate and concise records, uphold regulatory and quality system requirements including 21 CFR 820, 806, and 803; ISO13485; 98/79 EC (IVDD); and SOR/98-282 (CMDR).
  • Must be organized with strong attention to detail.
  • Able to prioritize and balance workloads to meet critical deadlines
  • Readily adapts to changing priorities, effectively manages own time, sets priorities to ensure tasks, multiple projects are prioritized and completed on time.
  • Must possess exceptional communication (written and verbal) skills, interpersonal skills, problem solving, and ability to interact effectively with all levels of the organization both internally and externally.
  • Ability to speak in large groups and actively engage participants.
  • Strong background utilizing MS Office applications (Word, Excel, PowerPoint, Outlook); experience using eDMS, workflow creation a plus.
  • Ability to read, understand and follow all company SOPs and guidelines.
  • Ability to maintain regular attendance and punctuality requirements. Ability to work additional hours as needed to meet critical deadlines.

 

Requirements (Physical, Mental, Environmental Demands):

  • Ability to walk up and down several flights of stairs throughout the work day in a multi-location facility.
  • Must be able to wear personal protective equipment (latex or nitrile gloves, face masks, safety glasses/face shields, lab coat, etc.).
  • Must be able to adhere to applicable bio-safety practices when on the manufacturing floor and in the laboratories.
  • Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the work day.
  • Ability to sit and stand for long periods of time, stoop, reach, bend throughout the course of the work day.
  • Must be able to analyze, concentrate, and solve complex issues routinely through the course of the work day and remain focused in a fast paced open environment throughout the course of the work day.
  • Must be able to travel, domestic or global, by car/air/train to other MBI locations, and/or supplier locations as needed

 

 

We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

 

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