Sr. Regulatory Affairs Manager

Danaher   •  

Orange, CA

Industry: Manufacturing & Automotive

  •  

5 - 7 years

Posted 56 days ago

About Us


KaVo Kerr is a cohesive organization comprised of two global leaders, united to provide dental excellence and serve as a single premier partner for the dental community. KaVo Kerr operates with a common vision inspiring and helping our customers, their patients and our own associates realize their potential. KaVo Kerr offers solutions for endodontics, restoratives, treatment units, infection prevention, imaging, rotary and instruments.


Description


Summary: This position is responsible for providing leadership and management to the global RA staff. Apply expert knowledge of FDA, US EPA, EU Biocides and MDD/MDR regulatory compliance. Additionally, developing and executing product approval regulatory strategies for product development teams; to ensure compliance with all applicable domestic and international standards and regulations that pertain to regulatory approval and maintenance on the market



Essential Duties and Responsibilities:

  • Develops RA strategy for new products and design changes, ensuring regulatory requirements for target markets are met.
  • Actively participates in defining customer requirements, product claims and target markets early in the product development lifecycle.
  • Manage and maintain US and/or international product registration submissions.
  • Manage internal processes to meet FDA, Notified Body and other regulatory authority requirements.
  • Ensures that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development and registration
  • Oversees maintenance of technical files, MDD/MDR certifications and declarations of conformity in support of EU product registrations/CE mark and biocides.
  • Supports audits and inspections of the company and its quality system.
  • Implements business unit (BU) goals and objectives; as related to areas of responsibility and sets regulatory goals and objectives for the RA team.
  • Formulate and establish clear objectives and work plans; review progress against objectives and establishes countermeasures, where necessary, to achieve success.
  • Participates in development, modification and execution of policies and procedures that affect one or more functional areas.
  • Ensure RA activities support pre-production and design releases of new product development.
  • Review and approve labeling and promotional materials.
  • As applicable within an BU, may also manage regulatory compliance activities such as HHEs, adverse event reporting and recall execution and reporting.
  • Prepare monthly status reports, Key Performance Indicators (KPI) for Regulatory Affairs Management.
  • Perform special projects as needed.
  • Scope: Domestic and International


Supervisory Responsibilities: This job has supervisory responsibilities. Able to lead teams and perform as a team member, superior communications and excellent interpersonal relationship abilities.



Qualifications


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.



Required:

  • Bachelor's Degree (BA/BS) from four-year college/university
  • 6+ years of Regulatory Affairs experience and/or training in an FDA-regulated industry
  • Must have management or project team leadership experience


Preferred Skills:

  • Master's degree
  • RAC certification desired.
  • Well-developed technical writing skills including presenting technical information in the context of regulatory requirements.
  • Strong listening skills.
  • Communications with regulatory bodies on significant matters, including formal response to regulators on submissions, with supervision.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Strong computer skills in Word, Excel and PowerPoint
  • Ability to effectively translate regulaltory requirements into practical advice to cross-functional teams and other audiences.
  • Crisp decision-making capabilities, delegation, managing to tight deadlines, prioritization of work for self and subordinates.
  • Decision-making abilities in the areas of adverse event reporting and/or field corrective actions, with supervision.