Regulatory Affairs Specialist

We have a temporary opening for our EMEA (Europe Middle East & Africa) Headquarters in Bussigny, Switzerland for a:

Regulatory Affairs Specialist

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In your kitchen, living room, bedroom, bathroom, garage and outdoors. We are already making your everyday lives better. How are we achieving this? We are powered by knowledgeable, enthusiastic, and forward-thinking people committed to developing a culture of inclusion. And whether you are just starting your career or in need of a new challenge, we recognize, develop, and empower talent!

Helen of Troy (NASDAQ: HELE) is a global designer, developer, and worldwide marketer of well recognized brands. Make an immediate impact on our trusted brands, including OXO, Hydro Flask, Osprey, Braun, PUR, Vicks, Honeywell, Hot Tools, Drybar, Curlsmith, and Revlon.

About the role

Reporting to the QMS & Regulatory Affairs manager EMEA, the regulatory affairs specialist supports all regulatory activities for the entire product portfolio focusing first on medical devices and Wellness appliances but could be also on Beauty appliances, all distributed in the EMEA region.

What you’ll do in the role

For medical devices (MD):

• Maintain regulatory documentation up to date for EMEA regulatory purposes
• Prepare of documentation dossiers to achieve timely regulatory approvals and maintenance of the existing portfolio
• Being in charge of all aspects of Technical Documentation (MDR 2017/745) for specific projects (NPDs and changes)
• Being in charge of MDR transition for the specific projects the person is working on (legacy devices)
• Work closely with product development, marketing and other teams to ensure and maintain compliance for all category of products
• Follow Post Market Surveillance activities including complaint reporting
• Follow Clinical Evaluation elements
• Are responsible for implementation of regulatory aspects of labelling

For wellness products:

• Work closely with product development, marketing and other teams to ensure and maintain compliance for all category of products
• Maintain regulatory documentation up to date for EMEA regulatory purposes
• Review all applicable test reports and ensure they are all up-to-date, applicable and sufficient
• Review initial release and changes for manager approval
• Prepare and maintain EU Declaration of Compliance / EU Declaration of Conformity
• Are responsible for implementation of regulatory aspects of labelling

Participate in QMS maintenance for MD:

• Propose improvements to ensure / maintain compliance with regulatory standards
• Participate during notified body audit and other inspections
• Support Post Market Surveillance activities including complaint reporting for MD

Support Middle East, Africa and APO notification and registration:

• Support sales demand for the specific product category(ies) the RA Specialist is in charge of

What will help you do the job well

🗝 Essential:

• University or Engineering Degree in Science or equivalent
• Ideally Minimum 2 years’ experience in a regulatory affairs position in the required product category(ies) area (preferred) and/or consumer industry in EMEA region
• Working knowledge of EN ISO 13485 and/or ISO 9001 requirements
• Working experience of the CE marking and CE compliance process plus WEEE/REACH/RoHs/CLPs for Medical Device. Knowledge of Low Voltage Directive / EMC Directive would be an asset
• Excitement about joining a midsize yet growing company with fast-growing brands! 👌

About you

Our ideal candidate is a self-starter, driven and passionate individual with exceptional communication skills. You have the flexibility to work in a small yet fast-growing organization, possess strong analytical and detail-oriented thinking, can work with a good level of autonomy and foster relationships with cross functional teams.

About us

Many of our products rank as #1 brand in their category- we are proud to be market leaders. Behind all these achievements stand exceptionally talented and passionate associates. We are a dynamic mid-size multinational company that offers challenges and opportunities equal to your talents and abilities. Our 15+ locations elicit unique team cultures; our powerful brands are marketed in approximately 75 countries.

If you want to join us on this journey you can find out more on www.helenoftroy.com/emea. You can also find us on our career website https://careers.helenoftroy.com/home or on LinkedIn, Glassdoor, Facebook, Instagram and Twitter.

What do we offer?

• 💸 Competitive compensation package depending on experience and skills
• 👂 Employee assistance counselling line
• 🩺 Collective Health Insurance
• 🚂 Mobility allowance
• 🎁 Employee discounts on all our EMEA products
• 💪 Lunch and Learns, a super motivated Learning & Development team delivering hard and soft skills training to challenge yourself and full access to a learning platform, where you can choose over thousands of courses to satisfy your hunger for knowledge.
• 🏝 Company closure between Christmas and New Year’s
• 👌 The chance to work in an international, diverse, and inclusive environment!

Sound like a perfect fit?

If you’re seeking an exciting professional position in a dynamic international environment and be empowered to inspire fresh ideas, then Helen of Troy wants to get to know you!

Next Steps: We will ask you to complete a quick survey as we would love to get to know you by learning more about your experience and skills. If your application is selected, we will reach out to you ASAP for a first informal introductory call.

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Incorporated in 1968, Helen of Troy has grown into a leading global consumer products company with career opportunities in North America, South America, Europe, and Asia. We offer creative solutions for our customers through a diversified portfolio of well-recognized and widely trusted brands, including OXO®, Hydro Flask®, Osprey®, Honeywell®, PUR®, Braun®, Vicks®, Hot Tools®, Drybar®. Most of these brands rank #1 or #2 in their respective categories.

We boldly bring brands into our family, where we nurture what makes them great. We collaborate internally and externally, always striving to provide the consumer-centric innovation, operational excellence, scale, global reach, and stellar shared services to make them soar.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and duties required of personnel so classified. Management retains the right to add or to change duties of the position at any time.