Regulatory Manager

Marmon Holdings, Inc.•Hillsboro, OR

About The Position

As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best. Job Scope The Regulatory Manager (RM) develops and implements global regulatory strategies for Acumed’s orthopedic implants from development through marketing approval. The RM provides regulatory leadership and ensures compliance with all regulatory applications including submissions, managing departmental projects, creating, and reviewing labeling, interacting with governmental agencies, and directing and managing department employees. Understand business needs and implement an aligned strategic plan. The RM provides leadership and direction in the creation and implementation of Regulatory policies, procedures, and strategies.

Requirements

Bachelor’s degree in life sciences, engineering or related field required, master’s degree preferred
Six to 8 years of experience in a Regulatory Affairs capacity requirement, prior leadership/management experience in regulatory environment preferred
Regulatory Affairs Certification preferred
Experience in implantable medical device manufacturing required
Extensive knowledge of cGMP, FDP QSR CFR 820, MDR, ISO 9001, 9002, 13485, CE and other international standards
Ability to liaise and interact with product development team members with a strong understanding of the product development process
Ability to manage timelines
Proven problem-solving skills and the ability to train teams to resolve various issues using available tools
Extensive knowledge and experience in implementation of Six Sigma quality concepts and techniques
Familiarity with Lean Manufacturing concepts
Knowledge and experience with ERP systems and their applications, SAP preferred
Exceptional organizational skills with extensive knowledge of MS Office (i.e. Excel, Word, Outlook)

Responsibilities

Establish and execute strategic plan for Regulatory Affairs.
Manage systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the FDA regulatory submissions process.
Author and publish electronic submissions.
Manage the development of dossiers for registration of products in countries outside the US.
Oversee the authorship and publication of electronic submissions.
Oversee subordinates in the preparation, organization, coordination of content/data and ensure regulatory compliance for submission to the FDA or regulatory agencies (e.g., 510(k), PMA, MDD/MDR Technical Files/Design Dossiers, global registration applications, etc.).
Assign Regulatory Specialists to serve on product development teams as core team members; devise and communicate regulatory strategy for new products.
Manage maintenance of required establishment listings for FDA, HC and, EU MDD/MDR including renewal or changes.
Initiate and maintain accurate international product registration, including renewal or changes, and certificates for foreign governments.
Manage correspondence with the regulatory and standards agencies or organizations such as FDA, MDD Notified Body, Health Canada, ISO, Acumed’s EU Authorized Representative.
Help develop annual operating budget and manage activities to achieve expected budget performance.
Develop and train staff to ensure appropriate skills/behaviors are present to achieve strategic objectives.
Perform annual performance reviews for direct reports.