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.

Supervise global reporting obligations and the management of communication between manufacturer, distributors and competent authorities for Solta medical device complaint activities, including assistance of and/or submission of medical device event reports in accordance with applicable local laws and regulations.

Responsibilities:

Supervising Product Surveillance Specialist team and providing daily oversight, understanding, and management of reporting of medical device complaint events and/or adverse events, follow-up, case processing and assessment for post-marketing activities including:

• Supervise and leadership/mentorship to Product Surveillance Specialist group.
• Assist in facilitating daily activities related to complaint management process.
• Create and conduct training for new hires.
• Subject matter expert for domestic and international government reports (MDR, MDPR, and MIR).
• Oversee and thoroughly review government reports in accordance with applicable local laws regulations.
• Collaborate in preparing responses to competent authority inquiry’s associated with medical device report submission (Serious Injury and/or Device Malfunction).
• Receive, document, and evaluate complaint information
• Review complaint manufacturing investigation reports and provides comments in accordance with procedures.
• Reviews and closes complaint files.
• Participate in preparation for Notified Body audits and or Competent Authority inspections.
• Participate in CAPA (Corrective and Preventive Action) activities.
• Evaluate metrics to ensure complaints and adverse events are processed in a timely manner
• As required, communicate with physician, physician’s staff and/or patient to obtain pertinent complaint information.
• Provide continuous improvement and enhancements for complaint procedures
• Performs all other duties as assigned.

Qualifications:

• Bachelor ‘s degree in scientific or business related discipline or equivalent experienced required (Biomedical, Engineering, Science, etc.).
• Minimum of 2-5 years in management role supporting the complaint management team.
• Knowledge of Medical Device Reporting regulations, Vigilance Reporting regulations, GMPs for medical devices preferred.
• Position requires strong written, oral and listening communication skills in order to interact with customer and other professionals.
• Must be able to generate and organize clear, concise responses when communicating with various levels of management.
• Superior organizational skills to be able to manage challenging deadlines.
• Adjusts to change with minimum or no interruption.
• Recognizes problems and suggests applicable solutions.
• Proficient in the use of personal computers, including database management, trending and word processing.

Language and Verbal Skills

The position will include interaction and communication with doctors and patients as well as internal business stakeholders. Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.

Math Skills

Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Analytical and Reading Skills

Ability to read, analyze, interpret and assist in the creation and refinement of company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.

Work Environment

Must be comfortable working in a company environment with rapidly evolving needs, responsibilities and expectations.

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 90K – 110K.

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.

This position may be available in the following location(s): [[location_obj]]

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.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch Health's Job Offer Fraud Statement (https://valeant.icims.com/icims2/servlet/icims2?module=AppInert&action=download&id=224770&hashed=-1624416981) .

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