Manager, Regulatory Affairs Aesthetics (Bothell, WA) 1 of 2

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. 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 it—where 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 $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.

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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