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Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

Are you an experienced Regulatory Affairs Specialist or would you like to start a new career in regulatory affairs? Do you want to drive and develop worldwide registrations of our Infusion set products? By joining a world-leading company specialized in the treatment of chronic diseases such as Diabetes and

Parkinson’s Disease you will be part of an exciting and rewarding endeavour to actually improve people’s lives. If you are ready for a challenging but very fulfilling job, then you might be our new Regulatory Affairs Specialist.

Every day, our products improve the lives of millions of people around the world. We are very proud of this;

thus, we are continuously transforming our business to reach millions more. Join us as our new Regulatory Affairs Specialist and help us drive progress that really means something to so many patients around the world.

Job Summary

Convatec Infusion Care is currently looking for a new colleague to join our dedicated Regulatory Affairs team. The RA department is responsible for Convatec Infusion Care product portfolio registration efforts and for ensuring local and worldwide regulatory compliance. You will be a part of a team of highly qualified and goal-oriented specialists who constantly aim at knowledge sharing, a high level of professionalism, and continuous improvement. While we set high standards for our work, we also strive for a healthy work-life balance and personal development. As our work is very dynamic, with many balls in the air at one time, you will have a unique opportunity to experience how a big corporation operates, conducts business, and has a positive impact on a global scale.

We offer you an impactful role in an innovative and far-reaching company. You will collaborate across the organisation and have a significant influence on the projects and processes assigned to you. Reporting to

the Senior Manager - Regulatory Affairs, you will join a team of highly motivated employees. The office is located in Søborg, Denmark - with the flexibility of working from home when it fits with your tasks.

Key Duties and Responsibilities

• Correspond with customers, appointed representatives in different countries and authorities regarding product registration;

• Ensure that registrations fulfill regulatory requirements in relevant markets;

• Maintain competence and knowledge regarding product registration and regulatory requirements in relevant markets ensuring that the impact of new regulations and changes in regulations are assessed and communicated within the organization, as required;

• Obtain knowledge of regulatory requirements to develop regulatory strategies for product launch and support registration in new markets;

• Provide regulatory support across the organization to ensure that the regulatory requirements are met, and that relevant product documentation is in place as required by regulatory authorities during the different stages of the product life cycle;

• Ensure that documents are generated and maintained for the registration of new devices, changes to existing products, and notification of said changes to the regulatory authorities. These documents include but are not limited to Declarations of Conformity, Technical File Summaries, regulatory statements, etc;

• Ensure maintenance of procedures and instructions related to Regulatory Affairs;

• Maintain regulatory Information in relevant databases;

• Ad hoc assistance within the regulatory field;

• Assess regulatory impact for changes to existing as well as new products;

• Sign documents related to products registration, according to the relevant procedures governing each document and in line with the responsibilities described above;

• Sign documents related to the development of new products and changes to existing products;

• Prepare, review, and sign Regulatory Assessment Plans.

About You

We are looking for a structured, positive, and team-oriented specialist. Additionally, you possess excellent communication and project management skills, along with comprehensive knowledge of worldwide regulations and MDR.

As a person who looks for solutions rather than obstacles, you take pride in being a specialist and aim to improve your personal and professional skills. You understand that the key contributing factor to success is collaboration with your closest colleagues and across functions. Delivering high-quality, timely solutions, and projects are top priorities for you. Having a strong grasp of good documentation practice, and habits of working in a structured and methodical manner, you know when to execute and delegate.

To be truly successful in this position you must enjoy cooperating within large project groups and having a busy workday while managing several tasks at the same time. You are fluent in English, in writing as well as verbally, as the company language is English.

Your Qualifications and Experience

• Engineer or technical/bachelor degree as Pharmaconomist, Laboratory technician, or relevant work experience (required)

• Customer service experience (preferred)

• Work experience with product registration/market access of medical devices or pharmaceuticals (preferred)

• Fluent English, verbal and written (required)

• Familiar with commonly used computer software packages

• Knowledge of regulations related to product registration (required)

• Knowledge of ISO 13485 or similar regulations, (preferred)

About us:

Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and to own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.

This is stepping up to a challenge.

This is work that’ll move you.

Note: Please send your CV only in English language.

Convatec, Infusion Care (Unomedicala/s) is part of a global medical technology business focused on serving people and caregivers. We develop and market sterile disposable products for subcutaneous infusion of various medications. Specialized in the treatment of chronic diseases, such as Diabetes Mellitus and Parkinson’s Disease. Our manufacturing facilities in Denmark and Mexico produce more than 100 million infusion sets per year, making us the world leader in this field. Further information about the company can be found on our website www.b2b.Convatec.comor www.Convatec.com.

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Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com .

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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