Solta Senior Manager, Regulatory Affairs

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. 

Reporting to the Sr Dir, Global Regulatory Affairs, the Sr Manager, Regulatory Affairs provides direct support to Solta operations for their globally distributed products. This role is not a regional regulatory but global regulatory position which under the organization of Solta Medical Inc.  They work closely with site Quality, R&D, Operations, and regional RA peers to support global licensing and registrations, and to ensure the effective execution and management of changes. 

Responsibilities
•    Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy for product portfolio which been assigned.
•    Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
•    Provides the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as US FDA product clearance, Health Canada registration, CE Marking, global product registrations, and clinical evaluations.
•    Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. 
•    Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. 
•    Ensures budgets and schedules meet corporate requirements. 
•    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.

Qualifications
•    10+ years of experience in medical device industry. 5+ years of experience in Electrical/Active medical device industry. 
•    5+ Working knowledge of appropriate global medical device regulations, requirements, and standards. 
•    2+ years of people management; direct & indirect. 
•    Should have experience of independently authoring complete 510k submissions, Health Canada Medical Device license applications (Class II or above), EU MDR technical file dossier (Class II or above).
•    Experience in participating in national or international standards activities. 
•    This position requires a minimum of an undergraduate degree, preferably in a science related field.
•    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.
 

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 $120K to $180K per year. 

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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