Senior Regulatory Affairs Specialist at BIOTRONIK, Inc. in Lake Oswego, Oregon

Job Description:

Senior Regulatory Affairs Specialist

As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

BIOTRONIK is looking to add a Senior Regulatory Affairs Specialist to our Regulatory and Compliance Team.  The Senior Regulatory Affairs Specialist role is suited for someone with experience in Class III and Class II U.S FDA medical device regulations. The role is responsible for providing regulatory expertise in support of Biotronik’s active and passive implantable devices by managing, preparing and submission of FDA premarket notifications and premarket applications.  This individual will also manage regulatory activities with respect to design, manufacturing and labeling changes, as well as review and approval of promotional material. The Senior Regulatory Affairs Specialist assesses regulatory requirements and provides training and guidance throughout the organization, including all aspects of the total product lifecycle.

Your Responsibilities

• Prepares and authors FDA submissions, including PMAs, IDEs and 510(k)s, Pre-subs and associated amendments, supplements and reports


• Researches regulatory requirements for FDA submissions and as requested


• Reviews and summarizes device design, software, and process verification and validation documentation for FDA submissions


• Works closely with international Regulatory Affairs counterparts (in Germany and Switzerland) and other departments to implement regulatory and product development strategies


• Tracks status of applications and report to internal stakeholders


• Tracks and maintain files on required registrations and reports


• Reviews and approves promotional materials 


• Maintains expertise in U.S FDA regulations and applicable standards


• Maintains systems to trigger and log regulatory reporting.


• Communicates information on regulatory requirements to other departments and business units.


• Develops and implements processes involved with maintaining registrations and listings.


• Determines requirements and options for regulatory submissions and approval pathways.


• Provides regulatory information and guidance for product development and planning throughout the product lifecycle, including for proposed product claims/labeling.


• Identifies the need for new regulatory procedures and SOPs and participates in development and implementation.


• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.


• Assesses the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable regulations.


• Creates work plans with appropriate staging of activities and with clearly defined milestones.


• Mentors and is a role model for regulatory affairs personnel

Your Profile

• Ability to understand scientific and health principles related to product development and regulations


• Excellent communication skills, especially technical and persuasive writing skills


• Ability to work on several projects concurrently, prioritizing work in consultation with manager


• Excellent organizational skills and attention to detail


• Proficiency with Microsoft Word


• Proficiency with Adobe Acrobat


• Ability to work with all levels of the company


• Demonstrated personal accountability and ethical behavior, including maintaining confidentiality of proprietary information


• Ability to clearly convey or exchange information with stakeholders within and outside the organization.


• Willingness to accept challenging assignments and new career opportunities that stretch and build capabilities.


• Ability to find and synthesize information from a variety of sources.


• Demonstrated resourcefulness to anticipate obstacles and take necessary steps to keep projects moving forward.

 
Required Education and Experience:

• Bachelor’s degree in biomedical engineering or related STEM field.


• Minimum of 7 years relevant experience with FDA regulations


• Minimum of 3 years of experience leading teams

 
Preferred Education and Experience:

• Experience working in the medical device industry 


• Technical writing experience


• RAC certification

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

Location: Lake Oswego, OR | Working hours: Full-time  | Type of contract: Undefined 

Apply now under: www.biotronik.com/careers

Job ID: 40482  | Contact: Amanda Willott  

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.