Regulatory Affairs Manager-Asia/Southeast Asia focus

at Terumo BCT

Denver, CO

Posted on Jul. 20, 2016

Performs regulatory activities and is responsible to manage product registrations and submissions for geographical areas as well as support management of the global standards linked to our products. Supports activities related to the launch of new products, maintenance of existing products and maintains regulatory compliance and regulatory systems for the company.

* Manages and provides leadership for the functional group's development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
* Understands the importance of regulatory compliance and timely submissions, ensuring that all regulatory activities are conducted in a timely manner with the highest integrity and in an ethical manner.
* Prepares/oversees the development of submission packages for international regulatory submissions with a focus on Asia and Southeast Asia as well as technical file support for EU devices.
* Acts as primary interface with regulators, presenting strategies and negotiating solutions.
* Shares experience with most stages of product life cycle and concentrates on new product development and post-market applications of existing products.
* Understands how product approval strategies interact with business strategies. Identifies regulatory and clinical challenges for Asia and Southeast Asian countries and develops solutions to address these.
* Communicates regulatory strategy effectively to all departments, RA department senior management, regulators, and regulatory agencies to achieve timelines.
* Creates an ongoing, proactive relationship and collaboration with internal scientific, marketing, and engineering colleagues.
* 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.

Bachelor's degree and experience sufficient to successfully perform the essential functions of the job may be considered.
Minimum 10 regulatory years experience with at least 2 years direct management experience

* Previous people management experience.
* Experience supporting regulatory operations in Asia and Southeast Asia
* Expertise with medical device regulations such as: ISO 13485, ISO 62304, ISO 10993, ISO 60601-1 and anticipated EU MDR.
* Knowledge and use of relevant PC software applications and skills to use them effectively.
* Demonstrated ability to communicate effectively both verbally and in writing.
* Knowledge of Blood Directive and regulations in additional geographies.
* Knowledge in gaining medical device approvals in foreign countries.
* Knowledge of technical aspects of regulatory profession, combined with scientific understanding and project management skills.
* 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.

Regulatory Affairs Certification (RAC) desired.
Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Some travel may be required (5-10%).
We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.
We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks.

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