Regulatory Affairs Manager

🕒 July 3

🇺🇸 United States – Remote

💵 $154k - $165k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 20%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Dentsply Sirona

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1899

🏭 Manufacturing

🏥 Healthcare

🧬 Biotechnology

Manufacturing • Healthcare • Biotechnology

Dentsply Sirona is a leading global provider of dental solutions dedicated to transforming dentistry worldwide. The company works with dental professionals in over 50 countries to deliver innovative and revolutionary products that enhance oral health. With a focus on research, development, and manufacturing, Dentsply Sirona aims to impact the dental industry positively both today and in the future, offering a range of opportunities in various business areas including sales, supply chain, and corporate functions.

📋 Description

• Oversee day-to-day functions of the Dentsply Sirona Implants and Prosthetics team • Develop regulatory strategies for existing, new, and modified medical devices and other regulated products • Lead and manage regulatory submissions, including FDA 510(k) submissions and technical files for CE marking • Manage communications with the FDA and EU notified bodies regarding pre-submissions, 510(k) submissions, and EU technical files • Provide regulatory guidance and support to cross-functional teams throughout the product lifecycle • Review and interpret regulatory requirements and guidance documents to ensure compliance • Coordinate regulatory activities with internal teams and external regulatory agencies • Review and approve product labeling and claims for US and EU markets • Stay current with regulatory requirements and update affected policies and procedures • Foster professional interactions with internal and external stakeholders • Mentor, coach, conduct performance reviews, create developmental plans, and support succession planning for less senior Regulatory Affairs professionals • Comply with company and departmental policies and administrative requirements • Perform other duties as assigned or needed

🎯 Requirements

• Candidates must be located in the US, ideally in the eastern time zone • Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline • 5(+) years of experience in regulatory affairs, preferably in the medical device industry • Experience leading regulatory submissions and managing regulatory projects • In-depth knowledge of FDA 510(k) and international regulations, including EN ISO 13485 and EU MDR • Proficiency with Microsoft Office Suite • Proficiency with regulatory software • Prior technical writing experience and proven track record with FDA and EU regulatory submissions • Leadership experience within medical device organizations • Strong leadership, project management, organizational, written and verbal communication, interpersonal, analytical, and attention-to-detail skills • Ability to work effectively in a team environment and independently • Knowledge of regulatory affairs principles and practices • Ability to critically review detailed scientific information and assess technical arguments and supporting conclusions • Willingness to learn and adapt to new processes and technologies • Eligibility to work in the country the position is based

🏖️ Benefits

• Target annual incentive • Remote working arrangement • Equal Opportunity Employer protections • Disability accommodation assistance during application