Director, Regulatory Affairs – Compliance and Systems
See job posting on website (click below) for a video of hiring manager discussing this role
Overall Objectives and Process
Understand organizational needs
Identify performance requirements to have an effective Regulatory Compliance and Systems program
Develop and Maintain compliance programs and processes
Active participation and leadership with other departments to complete compliance activities
In an increasingly regulated environment, the demands to assure the company understands and maintains effective compliance systems are fundamentally important to its success. Because the environment is changing with initiatives such as EU-MDR, MDSAP, New Country Requirements, this is driving a need to have and maintain a focused effort on Regulatory Compliance focus in the organization.
TBCT is going from $926M focused on medical technology to $1.26B company over the 5-year plan period. A good portion of the estimated $300M growth is expected to be derived from emphasis on new product development, reliance on more clinical studies to support disease indication and expansion in emerging markets. The activities associated with the firm’s growth in addition to new regulatory compliance requirements require that the company implement and maintain compliant systems that will assure that planned growth will not be impacted by regulator concerns.
We currently have approximately 50 Regulatory professionals located in various global locations. Each of these individuals have responsibilities as either product focused specialist, geographic location specialists or in Regulatory Operations. There is a need to have an individual who can coordinate with the global regulatory team to identify the regulatory and operations compliance needs and assure we have the appropriate systems in place to meet them. The individual will also have to work closely with other departments such as QA, Law and commercial teams in this effort.
Overall Challenges – What we are solving for
Regulatory Affairs Compliance
Increasing Demand for Regulatory Input on emerging regulations is driving the need to have focused efforts to assure the company goals and objectives are met, which include having a culture of compliance.
- EU-MDR CE marking in the future will require compliance to the new EU MDR requirements such as Eudamed Database inputs, Post Market Surveillance, Device classification changes and economic operator requirements.
- MDSAP implementation will require RA systems to comply with the expectations for this program.
- Expectations for in-country clinical trials is increasing in many emerging markets like China, India, SEA, LATAM and Russia will require Regulatory Support for guidance in various aspects.
- Our 5-year plan, focus shift from technology to diseases such as Autoimmunity, Cancer, Immunotherapy, Neurology, Nephrology and Trauma, will require expanded partnerships with healthcare service providers in these respective areas of clinical interest and will require fostering of clinical dialog.
- Labeling System upgrades will require knowledgeable RA input to label design and content
- Promotional and Advertising review processes will require Regulatory oversight and participation with coordinating effective reviews. This review may also extend to Press releases, Social Media posts and Medical Affairs material reviews.
- Acquisition and implementation of state-of-the art electronic data systems to facilitate e Submissions, Submission Tracking and assessments for regulatory filings of new or modified products will be an on-going process to meet both company demands for data and regulatory Compliance and submission requirements.
- Regulatory Participation and leadership in CAPA reviews, Failure Analysis Evaluations, Removal and Correction Decisions as well as product quality improvement programs will be an important aspect of the job. Having an incumbent that understands the requirements for these activities is critical.
Opportunity for regulatory leadership
Today, we lack bandwidth in the Regulatory Affairs department to provide the focus that is needed in the regulatory compliance area. Although the Regulatory Affairs role also includes submissions knowledge as part of the job activities, understanding and attending to the compliance requirements is equally important. This position is not a substitute for the QA department activities needed to assure product quality or other postmarket functions but rather this role compliments the compliance needs by identifying emerging requirements that apply to Terumo BCT, participating in the ongoing processes the company has such as CAPA review, product quality review and improvement, and Removal and Correction functions. It also looks for oversee the implementation of processes for submissions such as e-Copy or eCTD as well as focus on labeling and advertising review systems.
10 plus years of experience in Regulatory Affairs including a proven track record of implementing and or overseeing compliance processes such as: Labeling requirements, Promotion and Advertising review, Removal and Corrections, Post Market Surveillance reporting, CAPA systems, Document Management Systems, ECCR/ECO and Clinical Trial compliance to ClinTrials.gov.
Experience with participation in industry working groups such as AdvaMed Post Market WG, Advertising and Promotion WG, or Regulatory Strategy WG.
Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with FDA personnel is essential; Preference for candidates with global authorities
A visionary leadership role, with a “player-coach” mindset of both formulating and executing is of essence.
Collaboration, team work, working within matrix are norms of the “Raise the Bar” company culture of Terumo BCT and the leader must possess these.
Background in an industrial sector and adjusting to the nuances of global corporate culture is central to the success of this leadership role.
Travel is required, given the global scope of the job, and would vary in intensity depending on the evolving business needs, anticipated to be up to 20%.
The ability to effectively communicate both to educate and train the company associates on requirements as well as to promote a vision of compliance requirements.
Evidence of management responsibilities over professionals within field or beyond, and successful talent recruitment, retention and career progression of team members.
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