Regulatory Affairs Specialist

Regulatory Affairs Specialist - Schaffhausen (Life Cycle Management)

Location: Schaffhausen, Switzerland

Hours: 40h, Hybrid way of working (3 days onsite, 2 home office)

Essential: Medical Devices experience - support LCM Regulatory Affairs group, experience within European Council Directive 92/42/EEC or Regulation 2017/745, US FDA 510(k) submissions

The Role:

The Regulatory Affairs Specialist  leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, under minimal supervision. He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. 

In addition, the Regulatory Affairs Specialist may be involved in providing independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches.

Key responsibilities:

• Be the regulatory partner within Life Cycle Management (LCM) project teams

• Attend team meetings and provide the global regulatory plan, regulatory assessments and regulatory decisions

• Advise Manufacturing, as well as JnJ engineering and other support functions, on regulatory requirements and deliverables

• Assist reviewing product and process documentation for assigned projects, to ensure compliance with change control requirements and to aid determining any required regulatory activities

• Work with cross-functional teams to obtain relevant information and subsequent review of submission content as needed;

• Prepare regulatory documentation for company devices, including those required for CE marking technical documentation and submission to the Food and Drug Administration (FDA).

• Partner with local Regulatory groups, assist in the preparation of documents to support registrations in other major markets, as required.

• Capture and verify regulatory product status to support logistic and supply chain efforts on a global scale

• Provide progress of work-plans and the status of key project deliverables

• Ensure that the company's products comply with the regulations set up by government agencies

• Assist with the maintenance of regulatory databases (internal and external) with accurate and current regulatory information.

how to succeed:

• 3 to 5 years of experience in Medical Devices industry especially within regulatory, quality or alternatively within engineering 

• Strong knowledge of ISO 13485 and ISO 9001, QSR

• Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentation

• MEDDEV guidance documents applicable to Medical Devices products and processes

• FDA requirements

• registration requirements in further global markets would be an asset

• Strong understanding of change management, and Risk Management process,

• International experience preferred

• Proven exceptional written and oral communication skills

Other Requirements

• Familiar with Technical Documentation structure according to STED required 

• Teamwork oriented, within a multi-functional and multi-national team

• Strong interpersonal and diplomatic skills, customer / service orientated

• High analytical, planning and organizational skills; able to set priorities

• Strong knowledge and skills in MS Office

Benefits

This role offers a competitive hourly rate & a supportive working environment. 

About Johnson & Johnson MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.

For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

https://www.jnj.com/healthcare-products/medtech

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. Please apply via the link.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.