Operations Manager -Medical Device Certification

Company: DNV
Location: Medford
Posted on: May 22, 2023

Job Description:

Local Unit & Position DescriptionDNV's Healthcare Division is seeking to fill the role of Operations Manager - Medical Device Certifications. -The operation manager is the key liaison to the Global Competence Unit (GCU) and Notified Body units in Norway for the medical devices service line including primarily services covering the EU Medical Device Regulation (MDR), MDSAP & ISO 13485, among others. The position is responsible to improve the service development and delivery model on a continuous and sustainable basis in line with global procedures. He is also the primary local lead for recruitment, onboarding and competence development for production and delivery personnel.The position is home-based (North America) with some occasional business travel attending meetings with Global Competence Unit (GCU) and Notified Body units as well as industry trade shows (such as RAPS, MEDICA, etc.) as neededWhat You'll Do: Understand the procedural requirements for medical device services including assignment and scheduling of resources [on a global basis]; track project delivery adhering to tight timelines and expectations; facilitate project delivery from an end-to-end perspective concluding with final certification. Ultimately, this role is responsible to provide systemic transparency and visibility of all projects in line with accreditation rules, global procedures, and customer expectations.The Operations Manager will work in close collaboration with the local sales lead and management in developing and growing the medical device service line including expanding the competence scope of current delivery team. Moreover, this role is expected to grow its impact in DNV's global network collaborating with similar positions in other regions; members of the GCU and Notified Body units in Norway; and global program and competency managers, among others.The operation manager is the most knowledgeable person locally on global procedures and ensures that all activities are in line with them on a consistent basis. The role is expected to proactively work with GCU recommending improvements to global procedures.This position is a single contributor to begin with but is expected to have line management responsibility in a relatively short time leading resource competence development plans and looking for opportunities to expand the competency of the delivery team within the region. The successful candidate will also expected to support local management in preparation of the Annual Operating Plan providing critical analysis of the market dynamics, key trends and KPIs.Position QualificationsWhat is Required:

• Bachelor's of Science or Economics or related field -
• Minimum of 5 years of project management in a complex regulatory environment within the TIC industry -
• Demonstrated ability to coordinate to success projects and procedures in a complex matrix organization
• Leadership experience with recruitment, onboarding, and team development
• Self-learner, avid reader, interested in technical and scientific topics.
• Travel approx. 25% (domestic and international)
• Excellent English communication skills (reading, writing, speaking). - -
• We conduct pre-employment background and drug screeningWhat is Preferred:
  • Strong knowledge in medical device regulatory environment certification including MDD and ISO 13485, or equivalent
  • MBA, Masters in Economics or similar is strongly preferred
  • Fluency in Spanish (reading, writing, speaking) is a plus -How We Do ItWe Care, We Dare, We ShareDNV is a proud equal opportunity employer committed to building an inclusive and diverse workforce. All employment is decided on the basis of qualifications, merit or business need, without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.DNV is committed to ensuring equal employment opportunity, including providing reasonable accommodations to individuals with a disability. US applicants with a physical or mental disability who require a reasonable accommodation for any part of the application or hiring process may contact the North America Recruitment department (hrrecruitment.northamerica@dnv.com). Information received relating to accommodations will be addressed confidentially.DNV is proud to announce being named one of Houston's best places to work in the 2022 Houston Business Journal - Best Places to Work competition. - -For more information about your rights under the law, see: -https://www.eeoc.gov/know-your-rights-workplace-discrimination-illegal-posterRead more here:Diversity at DNV Meet our EmployeesAbout DNVCareers in DNVAs required by the Pay Transparency laws in Colorado, New York City, California and Washington, DNV provides a reasonable range of compensation for roles that may be hired in those locations. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For the state of Colorado, New York City, NY, California and Washington only, the range of starting pay for this role is $90000 - $150000Company & Business Area DescriptionDNV is the independent expert in assurance and risk management, operating in more than 100 countries. Through our broad experience and deep expertise we advance safety and sustainable performance, set industry benchmarks, and inspire and invent solutions.We are one of the world's leading certification, assurance and risk management providers. Whether certifying a company's management system or products, providing training, or assessing supply chains, and digital assets, we enable customers and stakeholders to make critical decisions with confidence. We are committed to support our customers to transition and realize their long-term strategic goals sustainably, and collectively contributing to the UN Sustainable Development Goals.Equal Opportunity StatementDNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity!

Keywords: DNV, Medford , Operations Manager -Medical Device Certification, Executive , Medford, Massachusetts