Regulatory Manager

Acumed LLC

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.

Responsibilities

• With executive oversight and approval, 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.

Qualifications

• 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)

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.