Sr Regulatory Affairs Manager - Enabling Technologies

Medtronic   •  

Louisville, CO

Industry: Manufacturing

  •  

8 - 10 years

Posted 48 days ago

The Senior Regulatory Affairs Manager provides senior level management expertise, direction, and leadership to the Regulatory Affairs Department and Medtronic Enabling Technologies business unit. These responsibilities include ensuring ongoing support of currently commercialized products, ongoing regulatory compliance, and support of new product development & commercialization worldwide.



A Day in the Life / Responsibilities:


• Ensure the timely and accurate filing of all regulatory documentation. Coach, mentor, and teach, and at times act as the Regulatory Affairs representative on product development and other cross-functional teams. Ensure compliance with relevant regulations.
• Oversee and have accountability for IDE, 510(k), PMA, CE Mark, Shonin and related regulatory filings. Collaborate cross-functionally to determine regulatory strategy from product inception to product launch. Participate in the short and long range planning of new product opportunities.
• Manage Medtronic Enabling Technologies relationship, activities, interface, and adherence to related guidelines with the FDA, Notified Body, Competent Authority, and other governmental regulatory agencies (supportive role for global regulator relationships).
• Assist in development and implementation of regulatory strategy and manage those systems and programs in order to meet Medtronic goals and objectives. Contribute to the development and implementation of franchise and business unit strategic and operating plans as appropriate
• Represent Medtronic before global regulatory agencies on major policy matters and decisions regarding Medtronic Enabling Technologies’ products and therapies.
• May contribute to the development and implementation of business unit strategic and operating plan
• Lead and manage activities that create and improve regulatory business systems, as appropriate, in order to facilitate accurate, timely, and sustainable regulatory compliance, submissions, and reporting activities
• Lead, manage, and direct staff to ensure alignment with overall department and business goals. Recruit, hire, train, manage, and develop regulatory affairs staff members. Maintain world class knowledge of current US, EU, and global regulatory landscapes, and of competitive regulatory and clinical activities. Regularly make impactful presentations to Medtronic Enabling Technologies senior staff. Develop and manage regulatory budget or portions of the budget as called upon. Procure and oversee outside vendors and consultants as required.
• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.
• Actively work to promote engagement, morale, Medtronic cultural guiding principles, and Medtronic leadership expectations within the department.
• Direct staff on process improvement initiatives and contribute to activities relating to regulatory initiatives by Medtronic in matters directly and/or indirectly affecting the business.
• Conduct annual performance reviews. Set objectives and devise professional development plan of staff.
• Participate as active member of due diligence teams when called upon. Provide expertise in regulatory matters during these activities.

Come for a job. Stay for a career.

Must Have: Minimum Requirements

  • Bachelor’s Degree
  • 7+ years of Regulatory experience in the Medical Device Industry
  • Experience with medical device regulatory submissions (510(k) or PMA)
  • 4+ years of management experience


SPECIALIZED KNOWLEDGE REQUIRED:

  • Knowledge of U.S. and European/International regulations and standards
  • Experience interacting with FDA and/or other regulatory agencies
  • Must work well in team environments
  • Must demonstrate leadership skills in team setting
  • Proven analytical abilities
  • Solid understanding of manufacturing and change control, and an awareness of regulatory trends
  • Understanding of engineering concepts and scientific terminology
  • Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationales
  • Experience reviewing technical and design specifications
  • Superior interpersonal skills
  • Excellent communication skills, both oral and written
  • Proven ability to prioritize, conduct, and manage time to meet project deadlines
  • Documented evidence of writing skills
  • Basic understanding of computer applications
  • Familiarity with medical terminology a plus
  • Some overnight travelrequired