at Terumo BCT
Posted on Oct. 5, 2016
JOB TITLE: REGULATORY AFFAIRS SPECIALIST
Working without significant direction, assists a company business in fulfilling regulatory compliance by applying a thorough understanding of regulatory/standards requirements to one or more areas of expertise such as the EMEA regulatory framework for blood component collections and processing.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Using a broad base of knowledge and understanding of regulatory requirements, assumes major responsibility for one or more major product areas and countries. Plans and arranges own activities, with work being reviewed upon completion.
- Interacts with and/or directs others in interacting with regulatory and certification authorities. As such, is recognized as an emerging authority within the business. Erroneous decisions or failure to act may cause delays or result in moderately serious consequences.
- Identifies the need for, prepares and conducts regulatory related training for the business.
- Identifies and defines contents for regulatory submissions/dossiers. Leads the assembly and creation of these documents for their timely submission to regulatory authorities.
- Proactively advises business management of regulatory and certification issues. Uses a positive, collaborative approach to creating solutions to regulatory/compliance challenges. Identifies areas where the business can effect improvements and establishes operating policies with direction.
- Stays current on changing regulatory requirements.
- Provides product development support, particularly in the area of certifications.
- Responsible for overall compliance with regulatory requirements that apply to the product development cycle. Makes and prioritizes recommendations on how to achieve compliance.
- Acts as liaison with regulatory agencies to facilitate product approvals and compliance issues.
- Provides regulatory support of clinical trials, local validation and verification trials and marketing trials.
MINIMUM QUALIFICATION REQUIREMENTS
Knowledge necessary to perform in this position is generally acquired through a Bachelor's degree in a related scientific discipline, business or industrial engineering.
- Three years experience in the medical device and/or pharmaceutical field.
- In depth knowledge of EMEA medical device and/or pharmaceutical regulations and standards.
- Working knowledge of and ability to prepare regulatory documentation.
- In-depth technical knowledge of European medical device and/or pharmaceutical and/or blood regulations, standards, policies, and guidance documents, including but not limited to:
* EU Medical Device Directive
* EU Blood Directives
* Clinical Trial regulations
* Labeling, advertising, and promotion
- Experience dealing with notified bodies and competent authorities
- Submission experience with clinical trial applications and CE marking of products.
- In line with Terumo BCT's Core competencies
(Approachability, Conflict Management, Integrity and Trust, Action Oriented, Decision Quality, Interpersonal Savvy, Perspective, Priority Setting, Drive for Results, Customer Focus, Creativity, Process Management)
- Demonstrated and effective leadership and team skills.
- Fluent in English and French (excellent written and verbal skills)
- Demonstrated ability to define problems and work with management to develop and implement solutions.
- A high level of initiative as well as willingness to take ownership and accept responsibility for actions and decisions.
- Demonstrated ability to interact with diplomacy and tact while maintaining appropriate assertiveness and persistence.
- Demonstrated analytical and creative thinking skills and the ability to solve complex problems.
- Demonstrated ability to communicate effectively both verbally and in writing.
- Demonstrated interpersonal skills and the ability to represent the business in contacts with those both internal and external to the organization.
- Exhibits commitment to organizational goals and guiding principles.
- Based: Brussels Office EMEA
- Reporting to: Regulatory Affairs Manager- EMEA
EXPERTISE: Regulatory Affairs
EDUCATION: Bachelor's degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
EXPERIENCE: Minimum 3 years experience