Solta, a division of Bausch Health, is committed to improving patients quality of life by delivering sophisticated technology in simple, elegant designs, providing true aesthetic and therapeutic benefits. For more than a decade, we've been developing innovative treatment technologies to provide proven and effective aesthetic care options to consumers and physicians alike.

This senior professional provides direct support to Solta operations for their globally distributed products. They work closely with site Quality, R&D, Operations, and regional peers to support global licensing and registrations, and to ensure the effective execution and management of changes.

• Develops regulatory strategies for new product launch & authors submissions for major markets (US, Canada, EU, China) as assigned.
• Facilitates the remediation of gaps for technical documentation for EU MDR compliance by working closely with teams and Notified Body.
• Evaluates product changes for impact to existing markets through engagement with international Regulatory professionals.
• Provides regulatory expertise to the R&D and Operations teams, including labeling requirements and submission approval lead times for new products and sustaining engineering changes.
• Acts as the primary interface between Solta and Solta’s global regulatory teams to support requests for Solta product information and documentation to facilitate regional regulatory submissions.
• Conducts research and communicates new and revised international regulatory requirements to the organization, performs/coordinates impact assessment activities, and supports implementation of changes as required
• Maintains and manages global Solta product market approval status, product technical files and a complex portfolio of product/process changes.
• Develops and maintains the underlying processes for this function including performance measures.
• Provides training as required to both international and domestic team members in support of the overall process.
• Represent Regulatory team in cross-functional meetings.

Qualifications

• This position requires a minimum of an undergraduate degree, preferably in a science related field.
• Requires 5-7 years of experience in Regulatory aspects of development, distribution, and life-cycle management of Class II and III medical devices.
• Experience with independently authoring 510k submissions, Medical Device license applications, EU MDR technical file documents, PTRs for class II medical devices and up
• Must have a solid understanding of Change Management / Life Cycle Management of medical device products along with the impact of changes on US and global product registrations.
• Possess a self-directed & problem-solving mindset.
• RAC preferred but not required
• 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.
• 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 $100 - $125k.

Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, 3-weeks paid time off plus 6 days paid sick time (unless a state or city-specific policy applies) to start (pro-rated for new hires), Employee Stock Purchase Plan, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating 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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This position may be available in the following location(s): [[location_obj]]

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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

To learn more please read Bausch Health's Job Offer Fraud Statement (https://valeant.icims.com/icims2/servlet/icims2?module=AppInert&action=download&id=224770&hashed=-1624416981) .

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Bausch Health is an EEO/AA employer M/F/D/V.