Manager, Regulatory Affairs - Medical Devices and Cosmetic Product Registrations

Job Summary :

This manager will serve as liaison between Dr. Dennis Gross brand holder and HQ regulatory team on the Dr. Dennis Gross medical devices regulatory compliance evaluation and registration ensuring all the products for registration meet and follow all regulatory requirements necessary to conduct business globally.

The Regulatory Manager is also responsible for the management and coordination of cosmetic product registration worldwide for Dr.

Dennis Gross and other brands, as assigned, under the Shiseido portfolio.

The Regulatory manager must be able to manage fluidly and apply both leadership skills and technical expertise.

Primary Duties & Responsibilities :

• Communicate with brand holder and HQ regulatory team to write, analyze, and edit technical documents for medical devices to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, in USA, Canada, Australia, and Europe.
• Manage the product registration group which is assigned with different brands to do product registration for cosmetic, OTC in the US, Canada, and other countries.
• Manage and oversee the preparation and submission of regulatory notifications and registrations as required by the US and international standards to ensure compliance and timely approval for market release of new and existing products.
• Direct the teams to review regulatory related information in the artwork and approve the artwork.
• Direct the teams to create registration request files (including creating and confirming list of products), upload request form, artwork files and registration document for each product to the company’s product registration system (APS).
• Ensure to provide documents to regulatory partners in other countries in time to meet the product registration timeline.
• Represent the regulatory department on various cross functional teams to launch and maintain compliant cosmetic products in the US and international markets.
• Communicate with brand holders closely with any issues of product registration that could impact the product launch timeline.
• Implement strategies to ensure effective documentation control and management of international product dossiers and compliance files.

Working Relationships / Key Stakeholders :

• Global Regulatory Team members including RSD, EMEA Reg, SAPAC Reg, SCH Reg and LA Regs
• GIC / AIC
• Brand Holders
• SAI and Operations
• Legal
• Contract Manufacturers
• Industry Associations
• Regulatory Authorities

Qualifications & Competencies :

5+ years in regulatory compliance and management with International and domestic product registrations for medical devices and cosmetics.

Familiar with EU medical device regulation (especially for MDR)

• Solid understanding of cGMP for Medical Devices, FDA, EU, and Australia Medical Device requirements.
• Strong project management skills to manage timelines of multiple product launching.
• Goal-oriented, proactive, able to multi-task, strong organizational skills.
• Excellent communication skills.
• BA / BS or higher.
• Good collaborator and communicator in a multicultural environment.
• Able to independently work and motivate a team.
• Capable of handling complex issues and solving problems with general guidance.
• Able to perform under pressure on projects with short timelines or multiple projects with the same deadlines. Complete all work in a timely manner.
• Fluency in written and spoken English is required. Foreign language (Japanese) abilities are plus.

Trust 8 Competencies : Below is a list of Trust 8 Competencies designed to help employees at Shiseido Americas succeed as the company continues to evolve and innovate.

Think Big : Adapt a big-picture perspective. Deliver new values through creativity. Take Risks : Embrace Risk, Practice Trial and Error and Trial .

Hands On : Consider Front-line realities when making decisions. Take the lead from end to end. Collaborate : Leverage the diverse capabilities of colleagues.

Be Open : Create an environment that encourages everyone to speak up. Act with Integrity : Be sincere and humble at all times.

Be Accountable : Commit to the goal. Take accountability for the execution. Applaud Success : Create a culture that celebrates success.

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Shiseido is an Equal Opportunity Employer and does not discriminate on the basis of race, color, gender identity, religion, sex, age, national origin, disability, veteran status, sexual orientation, genetic information or any other classification protected by Federal, State or Local law

Salary :

$93,480 - $140,220 / year