C. R. Bard, Inc.

Director, Regulatory Affairs

6 months ago
Industry / Category
Medical Device / Regulatory Affairs
Job ID
2017-10179
Career Level
management
Division
Warwick, RI / Davol Inc.
Relocation
Yes
US-RI-Warwick

Overview

Bard Davol Inc., a subsidiary of C. R. Bard, Inc., located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. We focus our business on key surgical specialties, including Soft Tissue Repair, Surgical Fixation, Biomaterials and Orthopedic/Wound Management Irrigation.

Our company has a strong tradition of developing our employees to learn, grow and excel.  We are continually building our team with qualified, team oriented individuals to enhance the success of our company.

Davol headquarters is situated in a central location, surrounded by a scenic coastline with easy access to T.F. Green Airport, AMTRAK Train Stations and Route 95, a major highway connecting to Providence, Connecticut, Boston and New York City within a short amount of time.                 

Summary of Position with General Responsibilities

The position of Director Regulatory Affairs is responsible for the development and leadership of the regulatory affairs function in a significant portion of the Davol product portfolio.  Through recruiting, hiring, supervision, and development of regulatory affairs personnel in the support of Davol product development and overall business objectives, the Director assures compliance with applicable regulations regarding all pre-market and post-market product support activities as defined within Bard and Davol procedures.

Essential Job Functions

  • Recruit, manage, develop and mentor regulatory professionals.
  • Prepare and manage annual budgets.
  • Utilize technical regulatory skills to propose strategies on complex issues.
  • Provide regulatory input to product lifecycle planning.
  • Working with regulatory associates, determine submission and approval requirements.
  • Assist in regulatory due diligence and acquisition transfer activities.
  • Through regulatory staff provide strategic input and technical guidance on regulatory requirements to development teams.
  • Manage and execute pre-approval compliance activities.
  • Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.  Build positive relationships with reviewers.
  • Monitor impact of changing regulations on submission strategies and update internal stakeholders.
  • Monitor and submit applicable reports and responses to regulatory authorities.
  • Maintain annual licenses, registrations, listings and patent information.
  • Ensure compliance with product post-marketing approval requirements.
  • Review and approve labeling to ensure compliance with regulations and company policy.
  • Review and approve advertising and promotional items to ensure regulatory compliance.
  • Assess external communications relative to regulations.
  • Review publicly disseminated information to minimize regulatory exposure, review product claims and preserve confidentiality of applicable product information.
  • Review and approve required reports, supplemental submissions and other post-marketing commitments to update and maintain product approvals and registrations.
  • Provide regulatory input for and appropriate follow-up to inspections and audits.
  • Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events.
  • Submit/review change controls to determine the level of change and consequent submission requirements.
  • Provide regulatory input for product recalls and recall communications.
  • Provide training for stakeholders on current and new regulatory requirements to ensure company-wide compliance.
  • Communicate regulatory agency/industry positions to internal stakeholders.
  • Strategize with and advise internal stakeholders on regulatory issues and requirements.
  • Conduct technical meetings with regulatory advisory committees and government agencies.
  • Accompany inspection team(s) as required.
  • Support and lead assigned improvement activities.
  • Notify, consult or brief legal counsel when appropriate.
  • Function as authorized delegate for function head when required
  • Prepare and take leadership in professional associations, industry/trade groups (local/regional/international) and appropriate standards organizations.
  • Special projects as assigned.

Basic Qualifications

  • Bachelors of Science required, with emphasis on life science or engineering.
  • Minimum of eight years knowledge and experience with regulatory requirements for medical devices (IDE’s, PMA’s, 510(k)’s, CE mark technical files and design dossiers) with prior experience supervising regulatory affairs professionals.
  • Broad knowledge of materials and manufacturing processes.
  • Must have demonstrated extensive working knowledge of the U.S.A. Federal Regulations for medical devices including those applicable to the import/export of devices.
  • Must have demonstrated extensive working knowledge with the requirements for medical device registration/licensing in the EU, (Medical Device Directive),Japan, Canada, Australia, Latin America and Asia/Pacific.
  • Previous experience in supporting regulatory projects and R&D/Quality teams.
  • Solid knowledge in FDA, EU regulations for medical device.
  • Good oral and written communications skills and ability to work on cross-functional teams.
  • Working knowledge of statistics and electronic documentation and information systems.
  • Ability to travel approximately 20% of time.

Additional Desirable Qualifications Skills and Knowledge

  • Familiarity with drug/device combination products preferred.
  • Advanced regulatory affairs training preferred – MS, RAC or other professional certification.

Education and/or Experience

*Determination of level will be based upon years of experience and demonstrated knowledge/skills.

 

Davol Inc. and C.R. Bard, Inc. are Affirmative Action/Equal Opportunity Employers, M/F/D/V.  VEVRAA Federal Contractor.

 

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