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Regulatory Affairs Manager

3 months ago

Lakewood, New Jersey, United States SS White Dental Full time
SS White Dental is seeking a Senior Regulatory Affairs Manager to support our Regulatory team. Candidates should have a strong background in Quality Assurance processes, plans and standards.

The Senior Regulatory Affairs Manager, is responsible for supporting New Product Development (NPD) programs as well as day-to-day regulatory activities across dental instrument platforms.

The Regulatory Affairs Manager both compiles and provides oversight to RA Associates in the creation of US FDA Submissions, EU or ROW submissions and is a key liaison with International Regulatory Affairs to support applications to global regulatory agencies for new product registrations and re-registrations.

This position is Remote eligible, with up to 25% travel on-site.
Primary Accountabilities

Reviews and interprets regulations/guidance documents to develop regulatory strategies to support SS White Dental projects (i.e., regulatory submission pathway, predicate device selection, submission requirements, validation approach, timing, risks, etc.).

Support interaction with US and/or International Regulatory personnel to define submission content, expedite pending applications, and resolve regulatory matters.

Actively lead the regulatory aspects of Technical Documentation/Technical File reviews and conversion to EU MDR requirements for upcoming audits and certification reviews.

Develop and implement company and departmental SOPs, as required.
Review critical regulatory documents/submissions and responses to regulatory agencies as needed.
Represents RA function across projects for both NPD and Sustaining Product Management Teams.
Perform other work-related duties as assigned
Qualifications

Minimum Education/Experience Requirements:
Requires a B.S or higher degree, preferably in scientific, engineering or quality assurance related disciplines

Requires minimum 5 years of regulatory experience in a medical device manufacturing environment with a proven track record of obtaining regulatory agency approvals.

Regulatory Affairs Certification (RAC) or Masters Degree in Regulatory Affairs can count towards 1 year of specific RA experience.

Must possess and demonstrate an understanding of European Medical Device Directive (MDD), Medical Device Regulations (MDR), and quality system requirements.

Must have a minimum of 1 years' leadership experience.
Must have strong organizational skills, detail orientation, strong leadership and critical thinking skills.

Must be able to work in a fast-paced environment, multi-task, and have good communication skills, both verbally and in writing.

Travel of up to 25% on-site.
Knowledge, Skills, And Abilities
Strong results orientation and effective change agent
Knowledge of Quality Assurance and Regulatory Affairs principles
Knowledge of 21 CFR 820, ISO13485, and MDSAP Compliance.
Skills in problem solving; including the ability to identify and appropriately evaluate a course of action.
Skills in trouble shooting and critical thinking.
Ability to build strong relationships across a wide spectrum of internal and external parties.
Ability to act independently on routine assignments or projects.
Ability to plan, organize and multi-task to complete assignments in an efficient manner.
Ability to communicate professionally, both oral and written.
Ability to pay attention to details and perform at a high-level accuracy.
Ability to work independently and with a team.
Why Join SS White Dental
We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family.
We invest in our employees' financial futures through 401k matching and an employee stock purchase plan.
We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.

We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.

We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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