Regulatory Affairs Manager

10 Jul, 2022

Jobs

Regulatory Affairs Manager

Essity
Charlotte, NC

Regulatory Affairs Manager

 

Essity is a global leader in health and hygiene with over 5000 employees in Business Unit Health and Medical Solutions (HMS) and 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.

 

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

The Essity’s Health and Medical Solutions team is searching for an experienced Regulatory Affairs Manager that ensures the 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.

 

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

 

Who You Are

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

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.

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

 

#LI-EB1

Additional Information

Among other requirements, our policy (COVID-19 Vaccination Policy: Mandatory) requires all office and sales employees to be fully vaccinated. You must submit evidence of full vaccination prior to the day on which you are scheduled to start your employment with Essity.  “Fully vaccinated” means two weeks have passed since an employee’s final COVID-19 vaccination injection.

 

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 EssityHRNorthAmerica@essity.com

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.

Learn more here

Job posted: 2022-07-10