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Senior RA Specialist (SEC)

CooperCompaniesNetherlands

30+ dagen geleden

Functieomschrijving

Job title : Senior RA Specialist (SEC)

Department : Regulatory Affairs

Location : Delta Park, Fareham / Hybrid

GLS : P3

Working hours : 37.5 Weekly

A brighter future awaits you

CooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. It’s more than making contact lenses, it’s about giving lens wearers freedom and confidence to move about their daily lives. We’re all about bright futures – for our people and those who wear our contact lenses.

At CooperVision, we’re big on belonging. Everyone’s contribution counts, and that’s why inclusion and diversity are so important.It isn’t just the right thing to do; it’s what makes our company the best it can be. We are committed to creating an inclusive and engaging workplace. Our Employee Resource Groups offer employees to grow within a safe and inclusive space. So be yourself, whoever you are, and let’s achieve amazing things together.

Job summary – What to expect :

As the Senior Regulatory Affairs Specialist, you will provide Regulatory support, guidance, and direction to products from concept to launch.

The Sr. RA Specialist will follow the company regulatory strategy for assigned corporate projects. Assisting in creating, developing, and implementing global regulatory affairs procedures for marketed products and to ensure company’s regulatory compliance status.

The Senior Regulatory Affairs Specialist also fulfils some of the responsibilities of the Person Responsible for Regulatory Compliance, per Article 15 (3) of the MDR, in a shared capacity.

Further responsibilities :

Registration Activities Prepares, compiles, and submits regulatory documents for the registration of current and new products in assigned markets. Maintains submission documents, and agile databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information. Monitors pending submissions to ensure timely approvals. Communicates to management any identified delays that may impact business expectations. Monitors approved registrations in respect to expiry and ensures management is aware of action required to renew in a timely manner to ensure no disruption in product distribution.
Monitoring Registration Requirements within Region Works with in-country representatives, contractors or perform independent research to determine regulatory requirements for product registrations in responsible regions Maintains up-to-date knowledge of regional and national regulations, guidelines, and advisory documents required for marketing CooperVision products in a specified region. Communicates applicable regulatory requirements to CooperVision Regulatory Affairs management and business partners. Analyses impact and communicates to management changes in regulations or requirements that have been identified.
Compilation of Technical Documentation Authors STED and GSPR documents and compiles Notified Body submissions in line with CooperVisionTechnical documentation procedures for MDD and or MDR. Supports RA Management with Notified Body requests for information.

PRRC

Ensures that, per Article 15 (3) of the MDR :

the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

the post-market surveillance obligations are complied with in accordance with Article 10(10) of the MDR;

the reporting obligations referred to in Articles 87 to 91 of the MDR are fulfilled;

in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of the MDR is issued.

This individual has autonomy to perform the duties of Person Responsible for Regulatory Compliance (PRRC) under the EU MDR. This individual shall suffer no disadvantage within the organization in relation to proper fulfilment of his or her duties in lieu of article 15 of the EU MDR.

A full job description is available upon request.

About you :

We are looking for someone who has understanding of ISO 13485 requirements and EU medical device regulations.

Experience & Education :

Required

Bachelor’s degree in a scientific or technical discipline and working knowledge of medical device regulations.

3-6 years of medical device regulatory experience.

Technical writing experience. Has experience evaluating manufacturing changes for impact on global regulatory affairs submissions.

Medical device industry experience including strong working knowledge and experience with MDD and MDR.

Understanding of ISO 13485 requirements and EU medical device regulations.

Ability to read and understand technical material.

Experienced at reviewing and approving product labelling.

What we offer :

You’ll receive competitive compensation and a fantastic benefits package including; Private medical insurance, 25 days holiday, pension scheme, healthcare cover, life assurance, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more!

We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals, we’ll give you everything you need to help you achieve yours.

We also provide access to LinkedIn Learning to help you develop in you career and grow with CooperVision

What you can expect :

As a CooperVision employee, you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering a diverse and inclusive culture is and how different perspectives add value and contribute to our success. With our CooperPride, African Descent, Woman’s Impact Network and Mind Body and Wellbeing Employee Resource Groups, we offer opportunities for employees to learn and grow within an inclusive and safe space.