Solta Director, Regulatory Affairs

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) : 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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