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Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.

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.

+ Regulatory affairs professionals actively participate on NPI (new product introduction) project team, to ensure regulatory needs are integrated in advance of registrations and that all proper resources are present for the duration.

+ 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/studies

+ Regulatory affairs professionals responsible to complete 510(K), Health Canada, EU MDD/MDR Technical Documentations, STEDs for global registration purpose as appropriate.

+ Consult, review, and approve the Regulatory Affairs Assessment during NPI phases.

+ Establish product global regulatory expansion strategy along with Solta GSM (Global Strategic Management) team. Support and guide RA specialist who responsible for international registration cooperation, monitor regulatory approval status for assigned product portfolio.

+ Support the Solta Bothell CFT team inclusive but not limited to R&D, Supply Chain, QA by collecting, monitoring, analysing and interpreting product relevant regulations, guidance, and national/international standards.

+ Work together with Bausch Health Group PRC regulatory lead, ensuring regulatory compliance for Solta promotional materials and other promotional activities

Qualifications:

University degree in a life science or technical discipline.

6+ years regulatory experiences in MNC medical device company (aesthetic device is a plus).

Demonstrates profound knowledge and expertise in Active Medical Device international regulations, focus on US/Canada/MDR and APAC is a plus.

Experience on 510(K), Health Canada, EU MDD/MDR Technical Documentations, STEDs for global registration purpose as appropriate, related submission work.

Experience with complex regulatory activities, effectively and efficiently facilitates discussions with regulatory authorities.

Strong stakeholder management

Experience with/participation in Regulatory Authority Inspection/Audit

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 115-173K.

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), 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.

We are an Equal Opportunity Employer. EOE Disability/Veteran. 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.

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