Director Regulatory Affairs, Pre-Market
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.
Responsible for providing regulatory leadership to Regulatory Affairs, Quality Assurance, Research & Development, Operations, Sales and Marketing business units.
Relationships:
Key Stakeholders Serves as a Regulatory liaison with the FDA in matters of product registrations and licensing.
A key resource and partner for research & development, operations, sales, marketing business units.
Direct Management Reports To:
Senior Director, Regulatory Affairs Supervision/Managerial:
Acts independently and oversees a team of 4-8 technical managers and professionals.
Responsibilities May Include:
Directs, mentors and develops a team of technical managers and professionals to achieve interface defined objectives across the diagnostic business in partnership with other Meridian diagnostic cross-functional groups.
Establishes liaisons with regulatory agencies such as USA FDA, Health Canada, Australia TGA, etc.
or Meridian's designated Market Authorization Holders.
Drives Cincinnati regulatory teams to prepare submissions to, and secure regulatory approvals required for commercialization of Meridian IVDD products (Pre-Submissions, 510(k)s, et cetera); this role will also facilitate premarket submissions across other Meridian sites.
Assists with the budgeting, planning, management and execution of activities associated with regulatory strategy and changes, risk management, regulatory submissions, product realization, and post-market surveillance, across the total product lifecycle.
Authors and reviews technical protocols and data in support of clinical trials, validation, verification and product manufacturing for pre-market submissions.
Provides direction and oversight of evaluation of the regulatory impact of changes associated with product design change and routine change control in domestic markets.
Reviews, and helps provide guidance for product labeling, including Instructions for Use (IFU/PI), to ensure adherence to applicable regulations and standards.
Assists in management of third party and internal audits Directs/conducts training of new employees, reviews training documentation for co-workers to ensure compliance to regulations.
Knowledge, Skills and Abilities:
Extensive knowledge of US FDA device regulations, including, but not limited to FDA regulations regarding medical devices and labeling, cGMPs, etc.
Experience preparing pre-submissions, 510(k)s, PMAs, etc.
Knowledge and ability to perform regulatory review of company and corporate SOPs and ECOs.
Knowledge and ability to develop, review, and approve technical literature and promotional materials to ensure consistency and compliance with domestic promotional regulations.
Able to use Microsoft Office, including Word, Excel, PowerPoint, Outlook, etc.
Strong leadership ability and experience working with multiple business units or internal clients required.
Strong organizational, problem solving and project management capabilities.
Highly motivated, readily adapts to changing priorities, effectively manages own time, sets priorities for direct reports to ensure tasks, multiple projects are prioritized and completed on time.
Must possess outstanding communication (verbal and written), interpersonal, problem solving and customer service skills.
Education and
Experience:
Bachelor's or Master's degree in Biology, Biochemistry, Microbiology, Engineering, or Regulatory Affairs.
Professional certification (RAC) required.
7 -10 years related experience in an FDA regulated industry or equivalent experience; in vitro diagnostic device (IVDD) experience is required.
, A minimum of 7
years of direct management experience is required, remote management experience a plus.
Requirements Travel:
10-15 %.
Must be able to travel by car/air to other MBI locations as needed Physical:
Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility.
Must be able to adhere to applicable bio-safety practices when on the manufacturing floor or in laboratories.
Ability to sit for long periods, stoop, reach and bend throughout the course of the work shift.
Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.
Other:
Ability to concentrate, problem solve and review paperwork for extended periods of time.
Ability to analyze and interpret data 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.
#LIOnsite Company:
Meridian Bioscience, Inc.
External Company URL:
www.
meridianbioscience.
com Street:
3471 River Hills Drive Recommended Skills Advertising Auditing Biochemistry Biology Clinical Trials Coaching And Mentoring Estimated Salary: $20 to $28 per hour based on qualifications.
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.
Responsible for providing regulatory leadership to Regulatory Affairs, Quality Assurance, Research & Development, Operations, Sales and Marketing business units.
Relationships:
Key Stakeholders Serves as a Regulatory liaison with the FDA in matters of product registrations and licensing.
A key resource and partner for research & development, operations, sales, marketing business units.
Direct Management Reports To:
Senior Director, Regulatory Affairs Supervision/Managerial:
Acts independently and oversees a team of 4-8 technical managers and professionals.
Responsibilities May Include:
Directs, mentors and develops a team of technical managers and professionals to achieve interface defined objectives across the diagnostic business in partnership with other Meridian diagnostic cross-functional groups.
Establishes liaisons with regulatory agencies such as USA FDA, Health Canada, Australia TGA, etc.
or Meridian's designated Market Authorization Holders.
Drives Cincinnati regulatory teams to prepare submissions to, and secure regulatory approvals required for commercialization of Meridian IVDD products (Pre-Submissions, 510(k)s, et cetera); this role will also facilitate premarket submissions across other Meridian sites.
Assists with the budgeting, planning, management and execution of activities associated with regulatory strategy and changes, risk management, regulatory submissions, product realization, and post-market surveillance, across the total product lifecycle.
Authors and reviews technical protocols and data in support of clinical trials, validation, verification and product manufacturing for pre-market submissions.
Provides direction and oversight of evaluation of the regulatory impact of changes associated with product design change and routine change control in domestic markets.
Reviews, and helps provide guidance for product labeling, including Instructions for Use (IFU/PI), to ensure adherence to applicable regulations and standards.
Assists in management of third party and internal audits Directs/conducts training of new employees, reviews training documentation for co-workers to ensure compliance to regulations.
Knowledge, Skills and Abilities:
Extensive knowledge of US FDA device regulations, including, but not limited to FDA regulations regarding medical devices and labeling, cGMPs, etc.
Experience preparing pre-submissions, 510(k)s, PMAs, etc.
Knowledge and ability to perform regulatory review of company and corporate SOPs and ECOs.
Knowledge and ability to develop, review, and approve technical literature and promotional materials to ensure consistency and compliance with domestic promotional regulations.
Able to use Microsoft Office, including Word, Excel, PowerPoint, Outlook, etc.
Strong leadership ability and experience working with multiple business units or internal clients required.
Strong organizational, problem solving and project management capabilities.
Highly motivated, readily adapts to changing priorities, effectively manages own time, sets priorities for direct reports to ensure tasks, multiple projects are prioritized and completed on time.
Must possess outstanding communication (verbal and written), interpersonal, problem solving and customer service skills.
Education and
Experience:
Bachelor's or Master's degree in Biology, Biochemistry, Microbiology, Engineering, or Regulatory Affairs.
Professional certification (RAC) required.
7 -10 years related experience in an FDA regulated industry or equivalent experience; in vitro diagnostic device (IVDD) experience is required.
, A minimum of 7
years of direct management experience is required, remote management experience a plus.
Requirements Travel:
10-15 %.
Must be able to travel by car/air to other MBI locations as needed Physical:
Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility.
Must be able to adhere to applicable bio-safety practices when on the manufacturing floor or in laboratories.
Ability to sit for long periods, stoop, reach and bend throughout the course of the work shift.
Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.
Other:
Ability to concentrate, problem solve and review paperwork for extended periods of time.
Ability to analyze and interpret data 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.
#LIOnsite Company:
Meridian Bioscience, Inc.
External Company URL:
www.
meridianbioscience.
com Street:
3471 River Hills Drive Recommended Skills Advertising Auditing Biochemistry Biology Clinical Trials Coaching And Mentoring Estimated Salary: $20 to $28 per hour based on qualifications.
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