Solta Manager, Regulatory Affairs (WA)

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.

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 ensure the effective execution and management of changes.

About the Role :

• Develops regulatory strategies for new product launch & authors submissions for major markets (US, Canada, EU) as assigned.
• Evaluates product changes for impact to existing markets.
• Provides regulatory expertise to the R&D and Operations teams, including labeling requirements and submission approval lead times for new product development (NPD) and sustaining engineering changes.
• Conducts research and communicates new and revised regulatory requirements to the organization, performs / coordinates impact assessment activities, and supports implementation of changes as required.
• Develops and maintains positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.
• Audit / Support Regulatory related submissions to relevant countries : US, Canada, China & EU
• Represent Regulatory team in cross-functional meetings.
• Experience with APAC (China) a plus, not requirement.

Qualifications :

• This position requires a minimum of an undergraduate degree, preferably in a science related field.
• Should have over 7 years of experience as Sr. Regulatory Affairs Specialist.
• Should have experience of independently authoring complete 510k submissions, Medical Device license applications (Class II or above), EU MDR technical file dossier (Class II or above).
• 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.
• 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 $ 85K to $135K

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

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.

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