Regulatory Affairs - Manager

at Terumo BCT

Belgium, WI

Posted on Oct. 7, 2016

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The EMEA Regulatory Affairs Manager will perform all regulatory activities and manage product registrations and submissions for either product lines or geographical areas. As a key member of the Regulatory leadership team, the Regulatory Affairs Manager will play an integral role in helping launch new products and in maintaining regulatory compliance throughout the company.


* Understands the importance of regulatory compliance, submissions and communications.
* Ensures that all regulatory activities are conducted with the highest integrity in an ethical manner.
* Acts as primary interface with regulators, presenting strategies and negotiating solutions.
* Experience with most stages of product life cycle.
* Ensures timeliness of regulatory submissions, including vigilance reports, according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators.
* Will concentrate on new product development and post-market applications of existing products.
* Initiates own projects at the product level.
* Provides direction to subordinates.
* Routinely works independently on complex issues.
* Actively participates and provides input to cross functional teams.
* Ensures that projects are completed on schedule.
* Reviews completeness of submissions, checking for consistency of the "story".
* Responsible for projects and complicated, novel regulatory submissions.
* Understands how product approval strategies interact with business strategies.
* Develops and mentors subordinates on regulatory principles and key corporate values.
* Participates and promotes subordinate participation on cross-functional teams.
* Prioritizes and manages resources effectively to optimize the value for the overall business.
* Prepares/oversees the development of submission packages for national and international regulatory submissions.
* Familiar with requirements required to work with cross-functional teams on high-priority events.

* Identifies regulatory and clinical challenges and communicates these to senior management.
* Ability to collaborate with scientists and engineers and to be firm when requesting and discussing required data.

* Creates an ongoing, proactive relationship with internal scientific and marketing colleagues.

* Communicates regulatory strategy effectively to all departments to achieve timelines.
* Ensures that all outside official communications comply with the appropriate regulations and internally approved regulatory and marketing claims.
* Acts as an effective regulatory consultant to management and other functions, striving to achieve the goal of "one voice" from the Regulatory department.



* Minimum of Bachelor's degree (scientific degree preferred) or equivalent. An advanced degree is preferred.


* Minimum of 10 years regulatory experience with increasing responsibility in the medical device or pharmaceutical industry, and 1 year previous management experience (or equivalent).
* Experience in working with a regulatory authorities (e.g. FDA, ANSM, MHRA, etc.)
* Experience in working remotely with cross-functional and cross-cultural teams.
* A demonstrated track record of creating regulatory submissions from internal reports.
* Experience in gaining FDA or Notified Body approvals for devices.
* Knowledge of Blood Directive and regulations in additional geographies is a plus.


* In line with Terumo BCT Core & Leadership Competencies

(Conflict Management, Developing Direct Reports and Others, Managerial Courage, Business Acumen, Timely Decision Making, Building Effective Teams, Managing Vision/Purpose, Peer relationships, Priority Setting, Drive for Results, Customer Focus, Perspective, Dealing with Ambiguity, Process Management, Cross- Cultural Resourcefulness)

* Strong emphasis on technical aspects of regulatory profession, combined with scientific understanding and strong project management
* Understanding of how product introductions and regulatory success impacts business goals.
* Able to make ethical decisions and communicate choice between two good options.
* Ability to select best options from those with competing factors.
* Has established credibility and is not captured by group-think.
* Ability to explain regulatory requirements and pitfalls to project teams and colleagues.
* Ability to communicate confidently and effectively with regulators and regulatory agencies.
* Demonstrated creativity and the ability to think "outside the box".
* Proven judgment in difficult situations. (Basically the ability to sort through layers of grey.)
* Capability to interact with diplomacy and tact while maintaining appropriate assertiveness.
* Willingness to take ownership and accept responsibility for actions and decisions.
* Must be detail oriented, well organized and able to work both independently and in teams.
* Excellent interpersonal, verbal and written skills.
* Demonstrated ability to lead people, including direct reports, and get results through others.
* Ability to communicate effectively in both informal and formal settings.

Regulatory Affairs Certification (RAC) is a plus.

Expertise in Microsoft Office applications is required.


* Based: Brussels Office EMEA
* Reporting to: Senior Regulatory Affairs Manager
* There will be an occasional requirement to work outside of normal business hours, consistent with other Manager-level positions.
* Some travel may be required (15%)

EXPERTISE: Regulatory Affairs

EDUCATION: Master's degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

EXPERIENCE: Minimum 5 years experience