The Manager Regulatory Affairs provides direct support to Solta operations for their globally distributed products. They will work closely with site Quality, R&D, Operations, and regional peers to support global licensing and registrations, and to develop and implement regulatory strategies for sustaining compliance with domestic and international regulations throughout the product lifecycle.

About the role:

Product Lifecycle Management

• Oversee the regulatory aspects of post-market activities such as changes, modifications, enhancements, renewals, and lifecycle management of existing products.
• Collaborate with R&D, manufacturing, and quality teams to ensure that design changes, process changes, or new indications are compliant with regulatory requirements globally.
• Coordinate with regional RA Managers on the assessment of product changes.
• Prepare and submit regulatory documents for post-market surveillance, including annual reports, and other required documents.

Regulatory Submissions and Documentation

• Manage the preparation, submission, and tracking of regulatory submissions for product change updates, extensions, or modifications to regulatory bodies (e.g., FDA, EMA).
• Ensure that regulatory documents are completed in accordance with regulatory standards and company policies, including maintaining up-to-date product dossiers.

Cross-functional Collaboration

• Act as the key liaison between the global regulatory affairs team and other departments, such as R&D, clinical, quality assurance, manufacturing, and marketing, to ensure that regulatory requirements are met throughout the product lifecycle.
• Provide regulatory guidance to teams working on product changes, modifications, enhancements, or packaging changes.

Risk Management and Reporting

• Conduct risk assessments related to regulatory compliance, helping the company identify potential non-compliance risks and address them proactively.
• Report any non-compliance issues or regulatory challenges to senior management and recommend corrective actions.

Training and Development

• Train internal teams on current regulatory requirements, processes, and any updates to regulations.
• Develop and implement standard operating procedures (SOPs) for maintaining compliance in lifecycle management, manufacturing, and marketing.

Regulatory Intelligence and Reporting

• Stay informed about global regulatory trends and ensure the company is prepared for changes in legislation that may impact current or future products.
• Prepare and present regulatory status reports to senior management, highlighting regulatory achievements and potential risks.

Global Regulatory Compliance

• Ensure compliance with international regulations by staying informed of changes and helping with submissions in regions such as the US, EU, Canada, or Asia.
• Work with international teams to align global regulatory strategies and ensure compliance in multiple jurisdictions.

Qualifications:

• Bachelor’s degree required
• Minimum of 6 years of regulatory required
• Must have a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact of changes on US Canada and EU.
• Possess a self-directed & problem-solving mindset.
• Must possess the ability to work highly effectively in cross-functional teams and must thrive in a dynamic, fast-paced environment.
• Excellent written and communication skills.
• Should have experience authoring complete 510(k) submissions, Medical Device license applications (Class II or above), EU MDR technical file dossier (Class II or above).
• Please note, the head office is in Bothell Washington, and this is a Westcoast operation.

As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is 115K – 160K annually.

Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.

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