Regulatory Affairs Manager

Katalyst Healthcares and Life Sciences

Austin, TX

Responsibilities:

The primary job responsibility for this position is overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team
This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products
This role manages and submits 510ks for the products and manages communications with FDA including pre-subs
The individual will also be responsible for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements
This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance
Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally
Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking
Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions, and EU technical files submissions
Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle
Reviews and interprets regulatory requirements and guidance documents to ensure compliance
Coordinates regulatory activities with internal teams and external regulatory agencies
Reviews and approves product labelling and claims for the US and EU markets
Stays current with regulatory requirements and updates affected policies and procedures
Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships
Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, succession planning
Complies with company and departmental policies and administrative requirements
Performs other duties as assigned or as needed
ctively articulates and promotes Dentsply Sirona's vision and direction
dvocates on behalf of the customer
Values driven with an insistence on excellence
Promotes high performance, innovation, and continual improvement
Consistently meets Company standards, ethics, and compliance requirements
Resolves conflicts and fosters a positive working environment
Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline

Requirements:

5(+) years of experience in regulatory affairs, preferably in the medical device industry
Experience with leading regulatory submissions and managing regulatory projects
In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR)
Required Computer / Software Skills:
Proficiency with Microsoft Office Suite
Proficiency with Regulatory software
Strong leadership, project management, and organizational skills including attention to detail
Strong written and verbal communication skills
Prior technical writing experience and proven track record with FDA and EU regulatory submissions
Excellent interpersonal skills
bility to work effectively in a team environment and independently
Knowledge of regulatory affairs principles and practices
bility to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported
Willingness to learn and adapt to new processes and technologies
Leadership experience within medical device organizations
Strong results orientation and analytical skills
Clear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise

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Vacancy posted 3 days ago

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