Regulatory Affairs Senior Specialist

Zimmer Biomet; Warszawa; Remote; PLN 383,000 - 468,000; Full time

Job summary

Zimmer Biomet is seeking an experienced regulatory affairs professional to manage submissions and ensure compliance for medical devices. The role requires deep knowledge of FDA and EU regulations, including labeling, with several years of industry experience in orthopaedics or medical devices.

You will support product development teams and liaise with regulatory bodies, ensuring timely approvals. Remote work considerations exist for US-related activities, and a bachelor’s degree in engineering

Qualifications

• 5+ years of regulatory experience in medical devices.
• 2 years of experience in orthopaedic or medical device industry.
• 3 years of experience working with FDA and EU regulations (including labeling) and regulations outside of the US/EU.

Responsibilities

• Assist with regulatory submissions process; including the regulatory submissions process.
• Author and publish electronic submissions.
• Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval.
• Assist with research, analysis, and communication of information pertaining to the regulatory pathway for new or modified products.
• Provide regulatory direction to development project teams as a core team member; develop regulatory strategy for new products.
• Evaluate risk of proposed regulatory strategies and offer solutions.
• Review proposed labeling for compliance with applicable US and international regulations.
• Write, manage, and approve the development of package inserts.
• Review proposed product changes for impact on regulatory status of the product.
• Interpret and apply FDA regulations to business practices and provide regulatory input, advice, and guidance to the organization and design teams.
• Communicate with regulatory and governmental agencies

Skills

Regulatory affairs

FDA regulations

EU regulations

Medical devices

Risk assessment

Education

Bachelor's degree in Mechanical Engineering

Job description

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

How You'll Create Impact

• Assist with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process.

• Author and publish electronic submissions.

• Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to associates and affiliates.

• Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.

• Provide regulatory direction to development project teams as a core team member; develop regulatory strategy for new products.

• Evaluate risk of proposed regulatory strategies and offer solutions.

• Review proposed labeling for compliance with applicable US and international regulations.

• Write, manage, and approve the development of package inserts.

• Review, evaluation, and approve promotion and advertising material for compliance with applicable Regulations.

• Review proposed product changes for impact on regulatory status of the product.

• Interpret and apply FDA regulations to business practices and provide regulatory input, advice, and guidance to the organization and design teams.

• Communicate with regulatory and governmental agencies

What Makes You Stand Out

• Requires 5 years of experience in the job offered or related position.

• Requires 2 years of experience in orthopaedic or medical device industry.

• Requires 3 years of experience working with FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU. Requires experience with advanced anatomic knowledge.

Requires experience with the following:

• Knowledge of overall business environment, the orthopaedic industry and the marketplace;

• Relevant regulations pertinent to medical devices, biologics, drugs and combination products as applicable and

• Identifying risk in regulatory strategies.

Your Background

• Requires a Bachelor’s degree in Technical Engineering, Mechanical Engineering, or a related field, or a foreign equivalent.

Expected base salary of at least $108,701.00 per year depending on education and experience.

Travel Expectations

• Requires up to 15% of domestic or international travel. Permits up to 100% remote work in the U.S.

EOE/M/F/Vet/Disability