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’s 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

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

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

Job Type: Full-time

Pay: From $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Charlotte, NC 28209: Reliably commute or planning to relocate before starting work (Required)

Work Location: Hybrid remote in Charlotte, NC 28209

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