Manager, Regulatory Affairs Aesthetics (Bothell, WA)

Bausch Health; Bothell (WA); On-site; USD 115,000 - 160,000; Full time

Job summary

An established industry player is seeking a dedicated Manager of Regulatory Affairs to join their team in Bothell. In this pivotal role, you will oversee regulatory compliance for a diverse range of medical aesthetic products, ensuring adherence to both domestic and international regulations. You will collaborate with cross-functional teams to manage product lifecycle activities and regulatory submissions, while also providing guidance on compliance issues. This is an exciting opportunity to contribute to the health and well-being of millions globally while working in a dynamic and supportive environment that values innovation and excellence.

Qualifications

• Minimum of 6 years of related experience required.
• Solid understanding of regulatory compliance for medical devices.

Responsibilities

• Oversee regulatory aspects of product lifecycle management.
• Manage regulatory submissions and ensure compliance.

Skills

Regulatory Compliance

Change Management

Cross-functional Collaboration

Risk Assessment

Communication Skills

Problem-solving

Education

Bachelor’s degree

Tools

Regulatory Submission Software

Job description

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Manager, Regulatory Affairs Aesthetics (Bothell, WA)

Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.

We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.

Principle Responsibilities and Duties:
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.

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.

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:

• Should have a minimum of 6 years of related experience with a Bachelor’s degree or equivalent combination of training and work experience.
• 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).

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 to $160K per year.

This position may be available in the following location(s): United States - Bothell, WA

We thank you in advance for your interest in growing and developing with our company. Kindly note that in order for all stakeholders to be successful, we do require a minimum of one year in your current role before applying to another one. Please ensure you have discussed with your current manager the intent of applying to a new role.

Any exception will have to be authorized by your HR Business Partner.

We are 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.