Job Information
Bausch Health Solta Director, Regulatory Affairs in Bothell, Washington
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.
PRIMARY RESPONSIBILITIES
Provide regulatory strategy and guidance to the R&D, Supply Chain, Quality and Commercial teams including collecting, monitoring, analysing, and interpreting relevant regulations, guidance, and national/international standards.
Develop, consult, review, and approve the Regulatory Affairs Assessment during New Product Development and Maintenance of Business changes.
Provide hands on support, leadership, and guidance Bothell GRA team to complete 510(K), Health Canada, EU MDD/MDR Technical Documentations, Summary of Technical Documentation (STED) for global registration purpose as appropriate, and related submission work.
Partner with other regions to support product global regulatory expansion.
Work in collaboration with Bausch Health Group Promotional Review Committee Regulatory lead, ensuring regulatory compliance for Solta promotional materials and other promotional activities.
Ensure all tracking including the Regulatory Approval Matrix is up to date for all product portfolio/SKU based on regulatory approval status in every country/region.
Provide leadership to Solta Bothell Regulatory site team
To ensure establishment of procedures/best practices for key target markets for pre and post market regulatory activities and regulatory intelligence processes.
To actively participate on NPD (new product development) and MOB (maintenance of business) project teams
Maintain full knowledge of all company products and services
Represent the organization at regional industry organizations. (ADVAMED, IEC, AAMI, etc.) as needed.
PROFESSIONAL QUALIFICATIONS / EXPERIENCE
University degree in a life science or technical discipline.
6-10years’ regulatory experiences in medical device company (aesthetic devices is a plus).
3-6 years of people management, direct & indirect.
Demonstrates thorough 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 purposes as appropriate, related submission work.
Experience with complex regulatory activities, effectively and efficiently facilitates discussions with regulatory authorities.
Strong leadership and 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 $150K to $190K
Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, Discretionary 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.
This position may be available in the following location(s): [[location_obj]]
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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To learn more please read Bausch Health's Job Offer Fraud Statement (https://protection.greathorn.com/services/v2/lookupUrl/c29afa19-107c-4ce0-9f8c-cdaacd1f6318/176/af4e247fc99befe729755d44229317a5dc5e5807) .
Bausch Health is an EEO/AA employer M/F/D/V.