Job Description

Regulatory Affairs Manager

Essity is a leading global hygiene and health company dedicated to improving well-being through our products and solutions, essentials for everyday life.

In the unit Health and Medical Solutions, we manufacture, market and sell Incontinence Products and Medical Solutions. Our mission is to empower consumers, patients and caregivers with products and solutions to support healthy and active lives. We have sales and a strong presence in all relevant channels e.g. retail, pharmacies, medical device shops, online, home delivery, nursing homes and hospitals.

Our key brands are TENA (Incontinence Products), JOBST (Compression Therapy), Cutimed (Advanced Wound Care), Leukoplast (Acute Wound Care), Delta-Cast and Actimove (both Orthopedics).

We are also an award-winning company with a focus on and commitment to sustainability. In fact, Essity partners with the United Nations Foundation in support of Sustainable Development Goals to improve hygiene, health and well-being worldwide.

About the Role

Essity\xe2\x80\x99s Health and Medical Solutions North America team is looking for an experienced Regulatory Affairs Manager who will ensure that assigned product assortments within their regulated area are compliant with international and national regulations from innovation throughout their life cycle in the all relevant markets. Together with the business ensures that innovation projects and change projects fulfill customer, consumer and supply chain needs.

We\'re looking for people who embody our values, aren\'t afraid to challenge, innovate, experiment, and move at a fast pace. We\'re always looking for ways to improve our products and ourselves. If this is you, we\'d love to talk.

The ideal candidate will live in the Charlotte area as this is a hybrid position.

What You Will Do

• In alignment with relevant stakeholders, implements regulatory solutions for the assigned product assortment
• Keeps products and supporting processes updated with changes in relevant regulations
• Drives the regulatory part of innovation projects and change projects and educates and supports project leader and project members to safeguard regulatory compliance
• Ensures in non-project driven business processes such as marketing and sales, quality management, sourcing and supply that regulatory adherence\'s achieved and safeguarded both for global and local markets
• Contribute to creating, implementing and developing the regulatory strategy and all regulatory processes within their regulated area
• Performs regulatory training, propose and support the implementation of process improvements and support the creation of standard operating procedures
• Apply sound knowledge of international and local laws, regulations, standards and guidelines to the business
• Strong ability and willingness to learn specific corporate processes and procedures as they relate to corporate compliance of the company\xe2\x80\x99s portfolio of medical devices and other products.
• Interpretation and implementation of specific aspects of US Healthcare Policy as it pertains to the company\xe2\x80\x99s portfolio of medical devices and products in relation to market access and reimbursement.

Who You Are

• University degree in technical, pharmaceutical or life science studies
• Minimum 3-5 years of recent relevant work
• Knowledge of FDA requirements
• Knowledge of Health Canada and EUMBR preferred

About Our DEI Culture

Guided by our Beliefs & Behavior, our culture is the foundation that connects our history with our future. At Essity, care, collaboration and inclusion are more than buzzwords, they are practiced on an everyday basis. And with a purpose of breaking barriers to wellbeing, promoting gender equality and enable customers and consumers to lead a fuller life at all stages of life, DEI is in our core.

As we work in diverse teams across geographies, cultures and professional areas, inclusive leadership is something we expect from ourselves and each other. In our leadership platform, we express this as leveraging the power of differences. From experience we know that diverse and inclusive teams are key to innovate and profitably grow our business while simultaneously address our ambitious climate targets.

What We Can Offer You

At Essity, we believe everyone\'s learning and professional development is unique and want to empower employees to reach their full potential in a winning culture motivated by a powerful purpose.

Compensation and Benefits:

Expected Compensation

Competitive annual salary + annual incentive bonus + benefits

Pay offered may vary depending on multiple individualized factors such as knowledge, skills, and experience.

Along with competitive pay you will be eligible for the following benefits:

• United Healthcare PPO / EyeMed Vision Insurance / Delta Dental Insurance
• Wellness program provided through Rally
• Healthcare and Dependent Care Flexible Spending Accounts (FSA)
• 401(k) with employer match and annual employer base contribution
• Company paid Basic Life, AD&D, short-term and long-term disability insurance
• Employee Assistance Program
• PTO offering with Paid Holidays
• Voluntary benefits to include: critical illness, hospital indemnity, and accident insurance
• Employee discounts program
• Scholarship program for children of Essity employees.

Collaborative and Inclusive Culture | Empowering & Engaged Leaders | Working with Powerful Purpose & Sustainable Impact | Learning and Growing in your Career | Supporting Well-being & Sustainable Working Life | Life-changing Innovations | Competitive Total rewards.

Additional Information

The Company is committed to equal employment opportunity and providing reasonable accommodations to qualified candidates and employees pursuant to applicable law. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, military and veteran status, gender identity or expression, genetic information, or any other characteristic protected by federal, state, or local law.

If you require reasonable accommodation as part of the application process please contact

Together, we are improving lives, every day

Working at Essity is not just a career; it is a chance to directly make the world a healthier, more hygienic and safer place. With impactful innovations coupled with sustainable solutions, we strive to reach more people every year with the necessary and essential solutions for well-being.

Application End Date:

Essity