MicroAire Surgical Instruments, LLC. is a fast-growing medical device company seeking a Senior Regulatory Affairs Specialist with experience with 510(k) and EU/Notified Body submissions. MicroAire is one of four companies within Colson Medical, LLC., the medical group ofMarmon Holdings, Inc., under Berkshire Hathaway, Inc., a Fortune 100 company.
The Sr. Regulatory Affairs Specialist is responsible for: (1) providing direction in regulatory compliance matters and submission strategies to New Product Development (Innovation), (2) supporting timely domestic, EU, and other global registrations and approvals, and (3) supporting sustaining regulatory compliance activities, to continue to meet all applicable Regulatory Body requirements, under the direction of the VP, QA/RA and Compliance Officer.
ESSENTIAL DUTIES & RESPONSIBILITIES
Supports and/or provides regulatory direction to New Product Development (Innovation) teams:
Provides general regulatory direction; generates Regulatory Assessments; works on Regulatory strategies
Stays abreast of current global regulatory requirements and in particular target markets/countries where MicroAire products are or plan to be sold
Participates in Design Control activities; particularly, UPS, V&V activities, and Risk Management
Generates or supports 510(k) submissions
As part of Regulatory Assessments: identifies classification, associated standards, predicate device(s)
Prepares and submits 510(k)s to FDA (or supports activity)
Works with FDA reviewer/coordinates any responses necessary
Evaluates proposed changes to product via Guidance: Deciding when to submit a 510(k) for a Change to an Existing Device; generates associated Document to File
Generates or supports all EU/Notified Body (NB) regulatory submission work:
Maintains product family Technical Documents to all relevant NB requirements
Prepares and submits new product submissions to BSI (or supports activity)
Works with BSI reviewer/coordinates any responses necessary
Evaluates proposed changes to product as to “significant” changes; takes action accordingly; generates associated Documentation
Performs miscellaneous Regulatory work:
Supports submissions to Health Canada and MDSAP countries
Supports submissions/registrations to Rest of World (note that Int’l Marketing has responsibility for ROWs)
Participates in DCO review of process/product changes to determine the need for any regulatory activities; e.g., need for a new 510(k), letter to file, notification to regulatory bodies on significant changes, etc.
Provides guidance for Labeling requirements
May assist in the review of advertising and promotion requirements, labeling, manufacturing, and marketing for regulatory compliance, as needed.
Participates and makes recommendations regarding departmental plans and performs all essential duties and responsibilities within the company’s mission, vision and values
May coordinate the purchasing and gap analysis of new Standards
EDUCATION & EXPERIENCE
Education Requirements: Bachelor's Degree in related field or equivalent.
Minimum of five (5) years of relevant experience within the Medical Device Industry, in domestic and EU Regulatory submissions experience
Experience in dealing directly with FDA and EU global regulatory bodies
Experience working with electromechanical device or software controlled devices is desired
Experience in dealing with other global regulatory bodies, e.g., HC, MDSAP countries, is desired
JOB KNOWLEDGE, SKILLS & ABILITIES
Diligent fact finder, with excellent follow-through and record keeping.
Good verbal and written communication skills; excellent attention to detail.
Good interpersonal and organization skills.
Ability to apply basic scientific reasoning to resolve technical problems.
Proficiency in Microsoft Office and other job associated software
MicroAire is a manufacturer and distributor of powered surgical instruments, sterile-packaged disposable orthopaedic accessories, SmartRelease-ECTR, PAL power-assisted liposuction, and Endotine bioabsorbable implants. MicroAire is a team dedicated to enhancing quality of life: For Surgery…For Life.
MicroAire is located in beautiful Charlottesville VA. home of University of Virginia and two large hospitals, Charlottesville is consistently ranked as one of the best places to live in America. For more information and to apply for this position visit our website at www.microaire.com (EEO)