Regulatory Affairs Manager - Medical Device - Lakewood, CO | Biospace
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Regulatory Affairs Manager - Medical Device

Terumo BCT

Location:
Lakewood, CO
Posted Date:
7/7/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Manager, Medical Device, Regulatory, Regulatory Affairs,

Job Description


Performs regulatory activities and is responsible to manage product registrations and submissions for product lines and / or geographical areas.   Supports activities related to the launch of new products, maintenance of existing products and maintains regulatory compliance and regulatory systems for the company. Seeking candidate with software as medical device (SAMD, MDDS, High Level of Concern Software) experience.

ESSENTIAL DUTIES

•   Develops, or is responsible for the development of, regulatory solutions to problems of moderate to intermediate complexity that may affect diverse functional areas of the business or company or unusual complexity in the function
•   Provides technical guidance and regulatory training/mentoring to other Regulatory Associates and/or cross functional teams
•   Create new methods, techniques and/or processes across job areas or functions exerting  some influence on the overall objectives and long-range goals
•   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
•   Represent specific business areas or geographies as the primary contact, interacting and creating an ongoing, proactive relationship and collaboration with internal scientific, marketing, and engineering colleagues and/or regulatory authorities.  Coordinate activities with senior management team.
•   Responsible for overseeing regulatory compliance, development and timely national and international regulatory submissions, ensuring that all regulatory activities are conducted with the highest integrity and in an ethical manner
•   Reviews staff submissions to identify adequacy of sections, completeness and consistency of story and overall content of submissions, may be responsible for authoring submissions when needed
•   Represent departmental function, acting  as primary interface with regulators, presenting strategies and negotiating solutions, and may lead and coordinate intra- and inter-company projects
•   Interprets, executes, and recommends modifications to operating policies at business level.  Will establish operating policies within specific business operating area and recommend policies that impact other areas.
•   Shares experience with most stages of product life cycle and concentrates on new product development and post-market applications of existing products
•   Communicates regulatory strategy effectively to all departments, senior management, regulators, and regulatory agencies 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
•   Acts a leader who embodies regulatory expertise as well as business acumen with a positive corporate mindset

Requirements


Education

Bachelor’s degree in physical/biological sciences or engineering preferred, or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered

Experience

Minimum 10 years experience in Regulatory Affairs and at least 2 years direct management experience preferred
•   PMA experience a plus
•   Software as medical device experience desired.
•   Direct experience in gaining FDA or Notified Body approvals for devices or drugs or biologics
•   Experience in an environment where skills in negotiation, listening, persuasion, collaboration, compromise and analytic based judgment is used daily

Skills

•   Experience working with medical devices and software applications.
•   Demonstrated success in the management of regulatory submissions such as CE Mark for Class II-III products, IDE’s, IND’s, 510(k)’s, NDA’s, ANDA’s
•   Knowledge of technical aspects of regulatory profession, combined with scientific understanding and project management skills
•   Understands how product approval strategies interact with business strategies. Identifies regulatory and clinical challenges and ability to resolve them through collaboration
•   Recognized as an emerging authority within the business or function with broad understanding of and experience working with multiple functions that are unrelated
•   Able to manage ambiguity and have ability to fill gaps with alternative data
•   Expert with Regulatory issues involving multiple product lines, or geographies, or specific business processes and procedures
•   Possess business insight and have ability to understand how product approval strategy interacts with business strategy, may involve in creating/ proposing such strategy
•   Nimble learning and able to actively seek out relevant legislation and competitive information on product lines
•   Must be results oriented and decisive. Failure to obtain results or arrive at approproiate decisions in a timely fashion could impact compliance risk or cause delays in planned product launch.
•   Demonstrated analytical and creative thinking skills and the ability to solve complex problems
•   Able to mentor and develop talent of direct reports
•   Ability to interact with diplomacy and tact while maintaining appropriate assertiveness
•   Willingness to take ownership and accept responsibility, ensuring accountability for actions and decisions
•   Must be detail oriented, well organized and able to work both independently and in teams
•   Knowledge and use of relevant PC software applications and skills to use them effectively
•   Demonstrated ability to communicate effectively both verbally and in writing

Certificates, Licenses, Registrations

Regulatory Affairs Certification (RAC) desired.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.


PHYSICAL REQUIREMENTS

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.

Additional Physical Requirements

Some travel may be required (5-10%).