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SalaryAbout Us
BeautyHealth is a global category-creating company focused on bringing innovative products to market and delivering beauty health experiences by reinventing our consumer’s relationship with their skin, their bodies and their self-confidence.
Every person here is a key player in our success. We are firm believers in making the little things count each day so the big things will follow. If this sounds like you, come check us out! This is the perfect opportunity to work with some of the best leaders in the industry while you gain the global and strategic experience to add to your professional toolbox.
Job Description:
Hydrafacial is hiring a Manager, Regulatory Affairs, who is a key contributor in bringing the company’s products into new markets and spearheading global Medical Device/Cosmetic regulatory submissions. Serves as the internal subject matter expert for international Regulatory Affairs on assigned projects/regions, including labeling review.
HERE’S WHAT YOU’LL BE DOING:
- Lead all Regulatory Affairs projects to ensure compliance with all international, federal, state, and local facility/product registration, licensing, and reporting requirements for cosmetics and medical devices.
- Support in managing regulatory team members on project priorities and timeline execution.
- Assist with the development of regulatory processes to support the region and all other regulatory submissions, approvals, and inspections.
- Stay abreast with legislation and guidelines that apply to the organization’s product portfolio (cosmetics/medical devices).
- Work on a multi-functional team to determine the correct regulatory strategy in each market the company operates in.
- Oversight of the preparation and filing of regulatory documents with the FDA and international regulatory bodies; setting the standards for and reviewing all submissions to assure adequacy and accuracy.
- Communication with representatives of foreign regulatory agencies as needed to advance projects.
- Manage global trade compliance to support customs clearances and/or detention holds.
- Work closely with internal and external clinical affairs experts to review clinical study protocol and management of studies to support regulatory submissions, data integrity, promotional claims and claims substantiation based on product formulation.
- Keep abreast of changes in the global regulatory regulation landscape and communicate those changes to all stakeholders.
- Additional duties as assigned by management.
HERE’S WHAT YOU’LL BRING TO THE ROLE:
- 8+ years of combined Regulatory Affairs experience in the pharmaceutical and/or medical device industry, both domestically and internationally.
- Cosmetics experience is preferred.
- Bachelor’s degree; preferably in a scientific or engineering discipline.
- Excellent organization and time management skills to ensure project deadlines are met.
- An analytical and problem-solving mindset.
- Experience with requirements for international product registration.
- Ability to both understand and write technical documentation is required.
- A good command of English is fundamental.
What else can you expect with Hydrafacial? PERKS! We proudly offer full health benefits, that’s medical, dental, vision, FSAs, HSAs, Accident Insurance, and even Pet Insurance for your furry family to name a few. We also provide Basic Life/AD&D and Long-Term Disability coverage at no cost to you! Top these benefits off with an Employee Stock Purchase Plan and a 401(K) plan with an Employer Match.
Every person here is a key player in our success. We are firm believers in making the little things count each day so that the big things will follow. If this sounds like you, come check us out! This is the perfect opportunity to work with some of the best leaders in the industry while you gain the global and strategic experience to add to your professional toolbox.
We mean it when we say you’ll LOVE this role.
(Base Salary Pay Range: $130,000 - $150,000)
An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, travel requirements, revenue-based metrics, any contractual agreements, and business or organizational needs. The range listed is just one component of BeautyHealth’s total rewards package for our employees. Other rewards may include annual bonuses, long-term incentives based on level, paid time off, and region-specific benefits. Come grow and GLOW with us!
BeautyHealth is proud to be an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, sex, religion, sexual orientation, national origin, gender identity, gender expression, age, disability, genetic information, pregnancy or any other protected characteristic as outlined by color, federal, state or local laws. We are committed to working with and providing accommodation to applicants with physical and mental disabilities.
BeautyHealth does not accept unsolicited assistance or resumes/CVs from third party search firms. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral or CV/resume submitted by a search firm to any employee at our company without a valid written search agreement. If we need additional support, we will be sure to reach out directly to one of our preferred providers. Please no phone calls or emails
