Boston Scientific Maple Grove , MN 55369
Date: Sep 25, 2018
Location:Maple Grove, MN, US, 55311
Company: Boston Scientific
Additional Locations: US-MN-Arden Hills
Purpose and Passion Comprehensive Benefits Life-Work Integration Community Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your life's work.
About the Role:
The Director, Corporate Regulatory Affairs primary responsibilities include the identification, development, and implementation of strategic initiatives, franchise structure, and management development.
Directs and coordinates the Corporate Regulatory Affairs department
Responsible for providing leadership, global regulatory strategy and for setting internal and external regulatory policy working with BSC regulatory affairs partners.
Provides leadership for external regulatory policy globally. This role is responsible for providing a centralized point of contact for advocacy efforts and providing represenation for BSC in trade association efforts, where assigned. Responsible for supporting government affairs in regulatory matters, as requested. This role includes reviewing new and changing regulations and reaching out to key SMEs to adequately represent BSC and provide meaningful recommendations to influence external regulatory policy. Participates in trade and professional organizations.
Provides leadership and stewardship for global regulatory procedures. This role works closely with global counterparts to ensure various geographical implementations of local laws are not at odds with each other and do not create ever increasing requirements and costs for Boston Scientific. Reviews and approves, as applicable quality system procedures that require regulatory affairs evaluation prior to implementation.
Provides strategic input through participation on various global governance activities such as Labeling Governance Board, UDI Steering Committee, PLCP Governance Board, Corporate CAPA, Clinical Change Board, Notified Body Steering Committee, Regulatory Training, and Reporting Regulatory Requirements and Commitments during the RA Functional review.
Supports and cosponsors specific RA operational activities which are centralized cross-divisionally for the regulatory function.
Responsible for providing a centralized point of contact for regulatory support and identifying items, topics, trends which may need escalation or visibility to Senior RA Leadership (RASC).
This role is also responsible for leading a team which is responsible for and executes regulatory support and strategies for global projects. Such projects include but are not limited to Corp Research support, Digital Health, Mobile Apps , QMP, PTPs, Corporate CAPAs guidance onMulti-Divisional Product Changes such as centralized material changes, product changes at centralized distribution sites , manufacturing environmental changes etc..
Responsible for championing value improvement efforts for the global regulatory affairs function. This includes sponsoring process improvement initiatives initiated by the global regulatory function as well as the Value Improvement Leadership Committee
Establishes departmental priorities to meet company objectives.
Ensures compliance with all relevant regulations and guidelines.
Manages relationships with local regulatory agencies and notified bodies.
Partners with Clinical Affairs to provide input on clinical affairs procedures.
Advises divisional management team of prevailing and evolving global regulatory requirements and environment.
Provides regulatory guidance to postmarket function.
Fosters employee career development.
Provides Regulatory Affairs training to the regulatory affairs function, as well as other functions, such as finance, clinical, manufacturing and development teams.
Provides regulatory support in new business development activities.
Fosters relationships with business partners to ensure regulatory compliance.
Bachelors of Engineering, Science or technical degree and related development and design experience in the medical device with a minimum of 12 years in FDA regulated industry (or equivalent combination of experience and education)
Minimum 10 years people management experience
Ability to interact with senior leadership across the organization
Must have demonstrated leadership, coaching, employee development, influencing, and negotiation skills
Demonstrated presentation and facilitation skills required
Proven history of driving process improvements. Process excellence experience and experience leading change management projects. Experience with Lean Business Process (LBP methodology) is advantageous
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 436820
Nearest Major Market: Minneapolis
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