Job Description
Head of Quality & Regulatory is responsible for overseeing the development, planning and execution of the Quality and Regulatory strategies for Medtech Solutions (MTS). This role will lead all activities globally, ensuring compliance with internal processes/procedures, regulatory authorities, medical device standards and industry expectations. She/he partners with the MD Medtech and Leadership Team to effectively align the Quality and Regulatory approach to support MTS’s strategy. This role will provide expertise and guidance in interpreting government regulations, customer requirements, agency guidelines, and internal policies to assure compliance with global standards. Additionally, they serve as the top representative in the quality and regulatory departments for both internal and external functions by directing assessment and improvement of key business processes to ensure compliance with current and future regulations set forth by the US FDA and equivalent international bodies.
DUTIES AND RESPONSIBILITIES
Partner with MTS MD and leadership team in the development of short, medium, and long-term plans to achieve strategic objectives including operational optimization initiatives, strategic partnerships, and acquisition strategy
Provides strategic direction and guidance to MTS regarding Quality/Regulatory process, timelines and regulations
Creates an overall strategy for ISO. Develops and oversees a quality management system including all required documentation necessary to meet the requirements of the applicable ISO certification for each site including ISO 9001, ISO 15378 and ISO 13485.
Responsible for providing leadership, direction and technical expertise to global quality and regulatory teams across MTS
Define and implement a global regulatory intelligence strategy/program to meet & align with MTS business objectives.
Define and implement global regulatory compliance metrics and best practices, integrating product compliance into product marketing, sales, operations, supply chain/procurement and technology functions.
Work cross functionally with wider business team to ensure all company business objectives are met/exceeded
Coordinates with functional heads to implement effective collaboration and knowledge management measures.
Collaborates with the Technology teams to ensure they have appropriate quality and regulatory representation for all key development programs.
Provides quality and regulatory oversight of any contract manufacturing organizations supporting MTS.
Actively participate in global quality community efforts. Evaluate and implement best practices learned from internal or external sources.
Responsible for budgets and business planning for function across MTS and responsible for establishing and meeting department goals and objectives.
Partners with Operations to implement and continuously improve sitewide practices.
Actively engage in industry and functional forums and incorporate external best practices as appropriate. Become recognized as an industry thought leader and position Tekni-Plex as an industry leader.
QUALIFICATIONS
Education: Bachelor’s Degree in an applicable area such as quality, business, engineering or a technical discipline
Experience:
Ten (10) or more years of overall relevant experience with seven (7) or more years in a quality and/or regulatory leadership capacity in the pharmaceutical or medical device industry
Detailed knowledge and experience managing both the FDA 510K and FDA Pre Market Approval regulatory approval process for FDA Class III Medical Devices
Has implemented quality systems sufficient to gain ISO 15378 and ISO 13485 or other similar ISO level registrations
Has managed operational quality/regulatory teams previously, global experience a strong plus
Has held customer-facing roles within the Quality or Regulatory function
Demonstrated success leading, participating or completing compliance and customer audits
Demonstrated experience with continuously improving processes and systems throughout their career.
Proven success managing, leading and implementing process developments
Strong knowledge and understanding of the job to oversee the quality and regulatory functions of MTS operating globally. Strong familiarity of GxP Standards, ISO Standards and applicable regulatory authorities
Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals.
Ability to proactively identify areas for further investment or improvement. Recommends and sees solutions through to completion.
Ability to communicate at all levels of the organization, and other third parties.
Ability to establish credibility, trust and strong working relationships both inside and outside the Company.
Skill: Excellent interpersonal communication, verbally and in writing, with a diverse range of people; analyzing and independently solving a variety of difficult situations and problems;
Ability to travel (Domestically and Globally) up to 30% is required
Equal Opportunity Employer
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Job Tags
Contract work, Temporary work,