The VP of Regulatory Affairs is responsible for global RA strategy and execution for the Cardiac Rhythm Management (CRM) business. This position sets long-term global strategy and direction for regulatory processes and procedures consistent with a $2B business.
VP Level Qualifications:
- Participates as a major contributor on the Regulatory Affairs Steering Committee resulting in a strategic vision and proposed strategies for the corporation and local divisions. This includes global functional strategies.
- Reviews all aspects of the company's regulatory processes and systems, where necessary modifies procedures and policies to ensure world class regulatory organization.
- Provides hands-on supervision of all regulatory filings for all commercial divisions.
- Maintains relationships with all key internal customers and regulatory agencies and notified bodies. Interacts with the FDA (and international regulatory agencies) on a proactive, independent and frequent basis.
- Provides guidance and direction in taking innovative ideas from proof of concept through regulatory strategy, including filing and approval.
- Support and maintain Quality initiatives in accordance with BSC Quality Policy.
- Continuously assess and implement ways to improve Quality.
- Partners with Clinical Research to develop the most effective clinical trial strategies and protocols.
- Consistently identifies strategic opportunities to ensure company has focused appropriate resources to maximize success.
- Provides overall review, day-to-day management and operational success for all regulatory functions including the successful integration of activities with other organizational segments.
- Provides oversight, and when necessary, assists site directors in the management and timely presentation and submission of original IDE's, PMA's, 510(k)'s, and corresponding international registration packages. This includes the maintenance of all files, guidance of regulations and all pertinent documents.
- Recruits, develops, manages and mentors Regulatory Affairs professionals within the organization. Foster employee career development and ensure the complete required training.
Quality System Requirements:
- Bachelor’s degree, preferably in a scientific or technical discipline. An advanced degree is desired.
- Professional certification(s) preferred.
- Minimum of 10 years management experience in Regulatory Affairs necessary.
- Minimum of 15 years regulatory experience in either medical device and/or pharmaceutical industry is necessary with a combination of the two highly desired, including experience with active implantables
- Demonstrated success in developing and executing a global regulatory vision and strategy and implementation of such strategy through strong leadership and ability to work effectively cross-functionally.
- Strong and credible reputation within the regulatory profession, FDA and other Global Regulatory Institutions
- Successful record of achievement in regulatory filing and approval cycle in the healthcare industry resulting in the commercialization of products on time and within budget. In particular, previous regulatory experience within the Cardiac Rhythm Management industry preferred.
- Hands-on experience at developing submissions in device filing (IDE, PMA, 510(k)) is necessary
- Proven track record of product approvals including a successful track record of project management and the establishment of milestone of regulatory process and approvals, design dossiers and technical filing.
- Successful track record of building strong partnerships with other departments including Quality, R&D, Manufacturing and Clinical Affairs.
- Strong communication skills with experience in reporting and presenting at all levels of the company, including the Executive Committee and various entities outside the company.
- Ability to easily converse with technical professionals including Medical Doctors, Ph.D. Scientists, and Engineers.
- Proven track record of interacting and influencing regulators.
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality System.
Boston Scientific knows that nothing is simple in matters of the heart. The company makes medical supplies and devices used to diagnose and...