Senior Quality and Regulatory Affairs Specialist

  • Danaher
  • Cincinnati, OH, USA
  • Aug 01, 2020
Full time Government

Job Description

The Senior Quality and Regulatory Affairs Professional participates in all planning activities for Regulatory Affairs function for Mammotome with special focus on the US market and serves as a key member of the Quality and Regulatory Affairs Leadership Team. This is a strategic position that will support the planning and implementation of the Global Registration of Mammotome manufactured products, participate in strategy development, and will serve as the primary liaison with US Mammotome employees, as well as support to remaining countries and distributors around the world as needed.

RESPONSIBILITIES

  • Partners with the Quality and Regulatory Team, Engineering, Clinical, Operations, Manufacturing, Sales and Marketing to develop cohesive registration planning for existing products, new products and product and facility changes with main focus on US.
  • Provides early guidance concerning regulatory requirements, e.g., submissions, claims identification and substantiation, labeling, promotional materials and assuring the validity of clinical, ethical and regulatory compliance issues.
  • Reviews and approves all labeling for compliance, including all communications to trade publications, news media release, sales presentations and technical bulletins
  • Analyzes the support data for claims verification.
  • Collaborates and assists the Global Regulatory Team to support product compliance internationally.
  • Identifies specific US Regulatory legislation, develops strategies for compliance, and provides updates of upcoming changes as appropriate
  • Provides key support for US team and maintains electronic files and access to Quality and Regulatory technical documentation and product labeling to support tenders and Quality and Regulatory requests.
  • Provides leadership needed to instill a team-oriented and results-driven team.
  • Other duties as assigned.

REQUIRED EDUCATION, SKILLS AND EXPERIENCE

  • Bachelors Degree
  • Minimum of 8 years of Regulatory/Clinical experience in the food, drug, or device industry required.
  • Minimum of 3 years experience in a leadership capacity.
  • Deep understanding of global medical device requirements and practical experience in implementing or managing such activities.
  • Successful track record working in a global matrix/collaborative environment required.
  • Hands on experience in continuous improvement tools (DBS or equivalent).

DESIRED SKILLS AND EXPERIENCE

  • Oncology experience preferred.

CRITICAL SUCCESS FACTORS

  • Excellent communication skills, both written and verbal
  • Ability to gain followership and drive results
  • Positive attitude and ability to work closely with entire leadership team to drive change, continuous improvement, and engagement throughout the organization
  • The capacity to plan, organize, & complete projects on time. Excellent project management skills and ability to juggle multiple responsibilities and deadlines
  • Team player who can work well across a global organization

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here .