at Bausch Health in Peoria, Illinois, United States
Job Description
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.
The Head of Regulatory Affairs – Solta has the unique opportunity to lead strategy development & execution, and post-approval activities for the Global Regulatory Affairs organization.
This role oversees the development of regulatory affairs talent and capability with critical competencies in robust scientific thinking to meet current and future business needs and regulatory challenges. To successfully achieve this, you will partner strongly with other critical cross-functional groups including Quality, R&D, Marketing and Busines Development with a goal to successfully deliver on the company global innovation and strategy agenda.
This role will be onsite at our facility located in Bothell, WA.
Key Resposibilities:
+ Lead the creation and / or integration of the Global Regulatory Affairs organization to develop critical capabilities and competencies which are essential for addressing current and future business needs.
+ Identify, recruit and develop critical talent to enable a sustained, high-performing Global RA team
+ Effectively develop robust global regulatory strategies to drive innovation
+ Ensure aligned RA deliverables are in place and project plans are adhered to with respect to time, quality and cost.
+ Ensure that data are identified, obtained, and effectively presented for successful filing, approval, registration, market launch, maintenance of business and regulatory compliance – with strong focus on MDR compliance.
+ Active member of cross functional leadership team to ensure awareness of applicable regulations, requirements and standards.
+ Ensure high-value regulatory interactions with Regulatory Authorities worldwide, for assigned devices
+ Provide robust support with international markets to with respect to initial registrations, renewals and technical file updates, ensuring compliance throughout the lifecycle of the devices.
+ Diligently provide support with regulatory inspections by regulatory bodies, and actively engage in the formal response to any findings.
Key Attributes:
+ Demonstrates and actively integrates the company core values: accountability, agility, courage, integrity, teamwork and results orientation
+ Strong capability to contribute and lead a team environment
+ Capacity to react quickly and decisively in unexpected situations
+ Focused ability to influence operational excellence and performance metrics, while fostering a continuous learning and process improvement environment
+ Risk averse where needed with the ability to identify potential solutions to complex problems
+ Provides or exchanges information with internal and external stakeholders in a clear, accurate, complete and timely manner – presenting as a credible and reputable advocate for the organization.
+ Provides clarity and direction amid complex regulations and promotes solution-orientated behaviors
+ Adeptly leverages systems, tools and processes to effectively and efficiently lead the Solta regulatory function
+ Demonstrates knowledge of requirements and processes to compliantly maintain products on the market, including reporting and surveillance responsibilities
+ Demonstrated critical thinking skills ability and detailed analytical reasoning
+ Strong business acumen and sound ability to appreciate the commercial business drivers
+ Excellent communication skills in English; both oral and written
+ Robust interpersonal skills, with a strong ability to influence others, with or without authority, in a positive and effective manner
+ Demonstrates a firm knowledge and understand of domestic and international laws, regulations, and guidances that affect Medical Devices
+ Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
+ Ability to critically review detailed scientific information and assess whether technical arguments are clearly presented and conclusions are adequately supported by data
+ Adept at assessing project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
+ In depth knowledge of device EU Medical Device Regulations and maintenance of technical files & CE mark throughout the device lifecycle
+ Deep knowledge of US regulations, with extensive experience on 510K and PMA devices
+ Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses
+ Ability to interpret Regulatory Authority policies and guidance globally, firmly challenge and negotiate with authorities when and where required, to ensure they are applied appropriately and correctly for Solta products, with a clear goal of obtaining swift approvals with regulatory bodies globally.
Required Qualifications:
+ 10+ years relevant medical device and regulatory experience
+ 6+ years people management experience leading global regulatory affairs
+ Bachelor’s degree in science or health related field
+ Advanced degree preferred (MS, PhD, MD, or equivalent)
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.
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 $220-260k.
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.
