Regulatory Affairs Manager Jobs

Regulatory Affairs Manager

BioMedica Diagnostics is a proudly Canadian company and a member of the Scotia Investments Family of Companies. We focus on providing custom affordable diagnostic solutions in global health arenas.

Utilizing our innovative technologies and expertise in the field of Thrombosis and Haemostasis, we collaborate internationally with technology development companies and healthcare stakeholders to develop and manufacture customized reagents and diagnostic solutions to meet new and specific identified needs. Our success is predicated on our ability to deliver superior service, quality, and results to those with whom we collaborate, thus contributing to our partners’ ultimate success.

We invite applicants for the full-time role of Regulatory Affairs Manager at our facility in Windsor, NS. Reporting to the General Manager, the successful candidate will execute the following accountabilities as an integral part of the Leadership Team. This person will drive and accomplish business objectives through internal and external collaboration:

Market Access

• Ensure marketing and promotional materials and product labeling are compliant with labeling regulations.
• Manage and lead recalls vigilance procedures, health risk assessments.
• Responsible for managing the preparation and maintenance of regulatory and technical files required by regulatory bodies for introduction of new products and new markets.
• Investigate and establish CPT coding when necessary to optimize product reimbursement.
• Review changes made to in-market products to determine whether filing updates are required and provide annual vigilance reports for EU.
• Provide support and guidance on regulatory issues for all BioMedica Diagnostics functional areas while maintaining up to date regulatory guidelines and analyses on the impact of changes under GMP, ISO13485:2016 MDSAP and IVDR regulations.
• Complete annual registration and licensing of establishment and product licenses.

Quality Assurance/Quality Control

• Manage and maintain the implementation of overall Quality System to include but not limited to audits, complaints, CAPAs, supplier maintenance, document control, and continuous improvement.
• Represent BMD in customer and regulatory audits.
• Ensure implementation and maintenance of quality control program, including but not limited to instrumentation qualification, calibration and maintenance, product testing and release procedures.
• Assist in operational SOP revisions and maintenance.
• Responsible for Adverse Events reporting.
• Maintain Post Market Surveillance Plans and Reports and Periodic Safety Update Reports.

· Assist in development of validation protocols.

· Assist in other areas of site operations as needed.

· Oversee all aspects of quality control.

Fundamental Skills, Abilities & Attributes

• Technical knowledge of in-vitro diagnostic products
• Project management skills
• Strong knowledge and understanding of cGMP, ISO 13485, MDSAP and IVDR guidelines, policies, and regulations
• Effective communication with all stakeholders, including customers and government authorities. Abilities should include excellent presentation, writing, and editing skills.

Core Competencies

• Observant and resourceful.
• Ability to delegate responsibilities effectively.
• Methodical, detail and results oriented.
• Strong interpersonal skills.
• Strong communication skills - both oral and written.
• Ability to make independent, educated decisions.

• Ability to participate in Corporate Strategic Planning.

Preferred Competencies

• CGMP guidelines
• Medical Device development and design control

• Writing, editing and review of quality documents.

Education and Experience:

• University Degree/Professional Designation or equivalent learning and experience in a related discipline (i.e. Management; RAC)
• Minimum 2-5 years’ experience with quality assurance

BioMedica Diagnostics’ solid foundation starts with our diverse and talented teams. Our company culture is focused on honesty, commitment, quality, and integrity. We focus on career development and growth as we continue to look for fresh perspectives to foster innovation and further entrench quality in our solutions. We offer competitive compensation based on experience along with a comprehensive benefits plan. BioMedica Diagnostics is committed to creating a diverse environment and is proud to be an equal opportunity employer.

If you are excited by our values, our approach, and how we connect with our partners we would love to hear from you. Please submit your cover letter and resume in a single document to: [email protected].