Regulatory Affairs Manager

elemed; Zürich; Híbrido; CHF 120.000 - 180.000; Jornada completa

Descripción de la vacante

elemed is seeking a Regulatory Affairs Manager to lead regulatory strategy for a new implantable medical device, guiding US and international regulatory submissions and building a robust submission plan. You will ensure QMS compliance, liaise with FDA, and collaborate with global teams to enable timely product launch.

The role focuses on bringing a class III implantable device to market, navigating CE marking, and shaping regulatory processes in a cutting-edge, patient-centric environment.

Formación

• Experience bringing a class III implantable medical device to market.
• Led CE marking.

Responsabilidades

• Guide regulatory strategy for the NPI of the product into the US and international markets.
• Build submission files and prepare for regulatory approvals.
• Decode global medical device regulations to support product development teams.
• Identify regulatory hurdles and develop mitigation strategies.
• Ensure compliance with the company’s QMS and applicable regulations.
• Serve as the company’s regulatory expert with FDA and regulatory inspectors/auditors.
• Collaborate with global regulatory teams to support the product.

Conocimientos

Regulatory strategy

FDA interactions

Global regulation

QMS compliance

CE marking

NPI support

Descripción del empleo

Are you a regulatory professional interested in a new challenge - not just a new “job”?

One of the biggest challenges you can have as a regulatory professional is bringing a new innovation to the market! This is your chance to support a new product introduction to the USA!!

Don’t have USA experience? DON’T WORRY!!

As long as you have worked on a new product development and brought a product to market in the EU (CE marking OR USA) - you can be considered for this role!

We love this company because of its innovative and patient centric approach. This technology is state of the art and cutting edge, with connected health and embedded software elements, designed with patients in mind. Which makes your role as senior regulatory affairs manager even more interesting!

In this role, you will be the dedicated person responsible for all aspects of Regulatory affairs and regulatory strategy to help bring this product to market!

If working with cutting-edge technology, in an international environment, at the company’s headquarters is what you are looking for, look no further!

As Regulatory Affairs Manager

• Experience bringing a class III implantable medical device to market
• Led CE marking

The Role

As Regulatory Affairs Manager you will:

• Guide Global Success: Spearheading regulatory strategy for NPI of this innovative product into the US market and internationally. You will be responsible for building submission files and setting the stage for successful regulatory outcomes
• Navigate Regulatory Waters: Decode the intricate world of global Medical Device regulations, and provide valuable regulatory insight to guide product development teams.
• Problem Solve: Identify potential regulatory hurdles and come up with regulatory strategies to ensure a smooth journey to product launch. Identify and bridge gaps that could pose regulatory challenges.
• Quality minded: Ensure overall compliance with the company’s QMS and policies, and other regulations as required
• Partnership: Act as the company’s representative towards FDA and regulatory inspections and audits, and assist project teams in tailoring regulatory procedures, methods, templates, and tools for optimal outcomes.
• Foster Global Collaboration: Actively partner with global and corporate regulatory teams to be the point of contact and regulatory expert for this specific product, providing guidance and insights

Please note: Only candidates meeting the requirements set out in the role profile above, will be considered in the application process.

Due to the high volume of applications we receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.