Quality Assurance & Regulatory Specialist

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Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.

Our approximately 21,000 employees are united around our mission of improving peoples lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.

• Act as Medical Device Responsible Person / Quality contact for the company, as required by local laws and regulations, which may include but not limited to: corresponding with regulatory agencies, attending to any regulatory visits / inspections and maintaining product device information in the regulatory systems
• Ensure compliance with local regulatory and quality requirements, Solta Global Quality requirements and site quality system requirements.
• Responsible for new product registration, manage variation and renewals, and facilitate communication between regulatory agencies & Solta global & local functional teams
• Support the reporting and quality obligations in the country including submission of medical device event reports in accordance with applicable local laws and regulations
  

Quality

• Maintain QMS and certification within the site, including the the control of quality procedures and records
• Oversee quality processes such as product releases, product re-labelling, complaint investigations and reporting, change control, non-conformance, correct and preventive actions
• Where required, manage local QC testing with external laboratories including but not limited to: scheduling and payments, purchasing of reference standards and other consummables, communicating changes to test methods
• Monitor 3PLs, suppliers and service providers with regards to maintenance of product quality and compliance to quality procedures, through regular checks and audits
• Create quality awareness and educate and train employees on the organization QMS, local regulations and certification requirements
• Ensures site’s audit readiness and manage external regulatory and corporate inspections to ensure full compliance. Coordinate internal audits within the site
• Escalate critical quality issues and lead any field service corrections / market actions
• Perform post-marketing materiovigilance activities such as reportability assessments for complaints, submission of medical device event reports as required by applicable local laws and regulations, respond to regulatory agencies inquiries on serious Injury and/or Device Malfunction.
  

Regulatory Affairs

• Ensure ongoing compliance and maintenance of product registration to meet regulatory and business obligations
• Manage variation submission and approval for any change in the products and manage the renewal of product registration
• Communicate with local regulatory agencies to facilitate submission and approval of product registration, post-marketing surveillance testing and product enquiries
• Manage local labeling for new and existing products to comply with regulatory requirements
• Maintain up-to-date versions of product registration documentation such as technical files, testing reports, product master files
  

No

• All quality and regulatory activities in the designated country
• Regional Quality & Regulatory Affairs
• Local Supply Chain
• Local Commercial Team
• 3PLs, Suppliers and Service Providers
• Certification Bodies / local Regulatory Agencies
• Degree holder (Science related field)
• Basic ISO9001, ISO 13485, GMP and GDP knowledge
• Knowledge of medical terms, local medical device laws and regulations regulations, Vigilance Reporting regulations
• Expertise in the local GDP/GMPs for medical devices
• Auditing Skills (preferred)
• At least 3-5 years of experience in similar role or QARA experience in the pharmaceutical or medical device industry.
• Experience in quality organization in a commercial business.
• Exposure to ISO9001, GDP and GMP
• Good computer skills and experience in the use of electronic quality systems.
• Able to communicate effectively in English.
• Systematic and well organized.
• Takes initiative and ownership.
  

**This position may be available in the following location(s): [[location_obj]]**

Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please readBausch Health’s Job Offer Fraud Statement (https://protection.greathorn.com/services/v2/lookupUrl/c29afa19-107c-4ce0-9f8c-cdaacd1f6318/176/6d14a0b2d6ae791286e49cc8358d2a3ef29730f9) . Bausch Health is an EEO/AA employer M/F/D/V.