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Senior Regulatory Affairs Manager

📁
Quality and Regulatory Affairs
💼
Ormco
📅
526 Total Views

The Senior Manager, Regulatory Affairs will provide leadership and management to RA staff at Ormco BU, apply expert knowledge of global medical device regulatory environment, product and regulatory requirement to develop and implement global regulatory strategies.



PRIMARY 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 requirement, product claims and target markets early in the product development lifecycle.
  • Implements business unit (BU) goals and objectives as related to areas of responsibility, and sets Quality goals and objectives for the Regulatory team.
  • Ensures that resources and activities are aligned with the BU objectives. Effectively communicates progress, problems, and plans.
  • Manages and develops team of Regulatory professionals. 
  • Provides appropriate mentoring, appraisals, and discipline of direct reports.
  • Responsible for product registrations, state licenses, and annual reports for Medical Device products globally, through interactions with International Sales Team, in-country business partners and ministries of health.
  • Oversees maintenance, remediation of technical files, MDD/MDR certifications and declarations of conformity in support of EU product registrations/CE mark.
  • Oversee product recalls/field actions, including regulatory reporting per required timelines.
  • Foster and maintain strong relationships with senior RAQA Regulatory leaders across dental platform and leverage best practices and opportunities to drive cross business collaborations and initiatives.
  • Participates in audits and inspections of the company and its quality systems. 
  • Works within a cross-functional, matrixed global organization to drive dynamic performance in all areas.
REQUIREMENTS:
  • Bachelor’s degree in a scientific discipline.
  • 5+ years in RA role within Medical Devices or Pharmaceutical industries.
  • 3+ years of experience managing a team of RA associates. 
  • Ability to travel up to 10% of the time.

PREFERRED QUALIFICIATIONS:
  • Provide strong organizational leadership, ability to organize complex work, drive change and instill a culture of execution, in RA as well as across the broader organization.
  • Attracts, develops, and retains high quality employees, foster employee engagement and professional development.
  • Comprehensive knowledge and experience with global medical device regulatory requirements and product registrations.
  • Possess strong negotiation skills, the ability to interpret and apply regulations, and working knowledge of product development process.
  • Direct experience with preparing and submitting materials for 510(k), MDEL and CE mark.

Envista and all Envista 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 at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.

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