Acumed
  • 09-Jan-2019 to 10-Mar-2019 (PST)
  • Acute
  • Hillsboro, OR, USA
  • DOE
  • Salary
  • Full Time
  • Worksite – Acute Innovations

Medical, Vision, Dental, 401(k) match, Paid Time Off, Costco Membership Sponsorship, TriMet Pass, Summer Hours and more!


About Us

Acumed is a global leader of innovative orthopaedic and medical solutions developed to improve patient care. With over three decades of experience in the orthopaedic industry, our mission is to aid the afflicted through the ingenuity of our minds, the labor of our hands and the compassion of our hearts. The company is headquartered in Hillsboro, Oregon with a global sales and distribution network supported by offices worldwide.

Acute Quality & Regulatory Manager

The Quality and Regulatory Manager is responsible for directing Quality and Regulatory activities to support all aspects of Quality and Regulatory programs. They build successful teams, develop and lead people to achieve continuous improvement and drive change throughout the organization.  Fulfill duties of Compliance Manager under the guidance of Acumed's Chief Compliance Officer. Makes recommendations and coordinates changes related to federal and state laws and compliance with the AdvaMed Code of Conduct provisions and updates.

Duties/Responsibilities

  • Develops company regulatory strategies and determines priorities with sales and marketing, engineering, and quality. Create, develop, and maintain materials for regulatory compliance.
  • Execute requirements for international product registration, including certificates for foreign governments including renewal or changes.
  • Prepare, organize, and coordinate data for submissions to the FDA or regulatory agencies: i.e. 510(k), PMA, MDD Technical Files.
  • Fulfill duties of Compliance Manager under the guidance of Acumed's Chief Compliance Officer. Makes recommendations and coordinates changes related to federal and state laws and compliance with the AdvaMed Code of Conduct provisions and updates.
  • Ensures compliance to ISO, FDA regulations, and state laws.
  • Initiate and maintain required establishment listings for FDA, EU MDD and CMDCAS including renewals and changes.
  • Manage correspondence with regulatory and standards agencies or organizations such as FDA, ISO, CMDCAS, Intertek, and MediMark.
  • Lead the preparation and execution of ISO, FDA, and other regulatory agency audits.
  • Assure regulatory compliance and content accuracy of Device History Files, Technical Files, and 510(k) files.
  • Acts as approver of CDCR submissions for regulatory review.
  • Leads the development of IFUs and labeling.
  • Determines appropriate safety, regulatory, evaluation and testing requirements for new and approved products.
  • Product development design review team contributor, provide regulatory/compliance perspective and expertise, to assure products are in compliance with relevant US and foreign standards and codes.
  • Supervises regulatory personnel; develop and support employees through performance appraisals, 1-on-1 meetings, coaching.
  • Management representative for the quality system, which maintains compliance to FDA/QSR requirements.
  • Oversee quality and inspection operations.
  • Coordinate the inspection and quality duties throughout company.
  • Assure ongoing compliance to the Quality Assurance Manual.
  • Support and participate in the quality objectives within the company.
  • Supervise Quality personnel.
  • Qualifies and monitors vendors.
  • Reviews, approves, verifies, and participates in Corrective Action.
  • Analyzes quality data on a regular basis.
  • Completes the duties described in the Quality Assurance Manual.
  • Monitor internal auditing system.
  • Provide training to personnel on quality and other procedures.

Qualifications

  • Bachelors in Engineering or related field.
  • Minimum of 5 years leadership/management experience in regulatory or quality department preferred.
  • Six or more years of experience in medical device manufacturing.
  • Thorough knowledge and experience in FDA, CMDCAS, ISO, and MDD requirements and consensus standards.
  • Experience in the medical device or equivalent industry (quality, regulatory, or medical device engineering).
  • Experience and knowledge of the FCPA, False Claims Act, Starks(s) Law, the Anti-Kickback Statute, and the AdvaMed Code of Conduct preferred.
  • Proven problem-solving skills and the ability to train staff to resolve issues.
  • Exceptional organizational skills with extensive knowledge of MS Office.
  • Excellent leadership skills and ability to motivate others to work as a team towards a common goal, and a strong balance of strategic and tactical approaches, teambuilding, training, coaching and development.
  • Strong verbal and written communications skills with the ability to communicate at all levels of the organization in order to influence and get buy-in on process changes and system improvements to better meet customer requirements.

 

Acumed and ACUTE are equal opportunity employers. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with a disability.

As an equal opportunity employer, Acumed is committed to providing reasonable accommodations to applicants with disabilities. If you are interested in applying to Acumed and need special assistance or accommodation, please contact us at recruiting@acumed.net.

 

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