Solta Regulatory Affairs Specialist

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. 

Principle Responsibilities and Duties:
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.

This professional provides direct support to Solta operations for their globally distributed products.  They work closely with site Quality, R&D, Operations, and regional peers to support global licensing and registrations, and to ensure the effective execution and management of changes. In addition to this, they will also support administrative activities (as needed) for the regulatory department.

Qualifications

• Bachelor’s degree or equivalent in Biomedical Engineering, Bioengineering or a related field and 1-2 years of experience in position offered or related, including up to 1 year of experience within healthcare industry (medical devices preferred).
• Good understanding of  regulations in US, EU, LATAM or APAC.
• Excellent analytical and writing skills.
• Effective interpersonal communication skills
• Ability to work independently and under pressure (able to prioritize tasks, deadline oriented, good organizational and problem-solving skills).
• Committed attention to detail, accurate and meticulous
• Ability to handle multiple tasks/projects.
• Excellent technology skills, particularly expertise with MS Office (Word, Excel, etc.) applications.

Responsibilities

• Maintain regulatory documentation and electronic files, including updating databases to represent current regulatory registration status for products.
• Liaise with engineering project management, distributors and subsidiaries to provide relevant regulatory requirements and timeline for product registrations.
• Review product changes submitted by engineering and determine change impact on regulatory registration.
• Support requests for providing regulatory certificates for medical devices.
• Conduct research and communicate submission requirements and options to product development teams.
• Respond to additional information requests from regulatory authorities on product submissions within a timely manner.
• Prepare and support requests for routine reports, including certificates of quality and factory reports.
• Preparing or supporting technical file documentation for product registrations in major international markets (APAC, LATAM, EMEA); document authentication/legalization activities.
• Regulatory review of product development documentation, including requirements review, risk assessment review, design description reviews and verification and validation report reviews
• Support internal and external audits/inspections as required.
• Ensure files maintenance for compliance with regulatory requirements.
• Update of Technical Files as required along with developing strategy and creation of change notifications to regulatory agencies.
• Perform other administrative duties as assigned.

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 $70k - $90k.

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), 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.

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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