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Sr. Regulatory Specialist

Company: A-dec
Location: Newberg
Posted on: June 25, 2022

Job Description:

Overview:A-dec is looking for an experienced regulatory professional to join our Regulatory Team and help to execute our mission to ensure that A-dec's products are in compliance with applicable federal, state and international regulatory requirements. You will be responsible for developing strategies for, preparing and executing premarket submissions to global regulatory authorities to introduce new products to market and maintain compliance of existing products. You will advise internal stakeholders on regulatory requirements collaborate with regulatory agencies, authorities, service providers, and consultants, and be responsible for preparing new product registration packages and technical files. You must be adept at translating complex engineering and scientific principles into approachable content to educate others about A-dec products, processes and applicable regulatory requirements.Responsibilities:

  • Prepare and coordinate documentation for regulatory submissions, product registrations, license renewals, and annual registrations in domestic and international markets (e.g. FDA 510k, Canadian licenses, CE mark, NMPA registration).
  • Develop regulatory strategies for new devices and post-market changes to ensure business goals are met. Clearly communicate strategies and associated risks to Regulatory and Legal management and project teams.
  • Represent the Regulatory Team on product development teams to identify regulatory requirements and ensure they are incorporated into the development process.
  • Partner with cross-functional teams to proactively identify and execute regulatory requirements as needed and ensure timely and accurate record keeping.
  • Proactively research and review information from external sources to stay abreast of regulatory and technical developments in the industry. Evaluate impact to A-dec in order to achieve and maintain regulatory compliance. Provide regular, accurate regulatory recommendations, updates, decisions, training, and feedback to internal stakeholders, including product development and manufacturing teams.
  • Provide post-market support for products, as necessary, to ensure compliance with regulatory requirements. This includes reviewing labeling, promotional/marketing materials, product/manufacturing process changes, and other documentation for changes requiring submission to regulatory authorities.
  • Interface with regulatory authorities on projects/products as needed.
  • Create, maintain and support Regulatory Team processes and procedures.
  • Assist with training junior regulatory affairs professionals and provide work direction on projects of large scale with significant business impact.
  • Perform other duties as required.Qualifications:
    • Bachelor's degree in Biology, Chemistry, Engineering, or Regulatory Affairs or related discipline, and 5+ years of experience in medical device regulatory affairs or the equivalent combination of education and experience.
    • Demonstrated working knowledge of federal/international medical device regulations, guidance, and standards (e.g., FDA, CMDR, MDD/MDR, international) applicable to A-dec products.
    • Demonstrated proficiency in writing and submitting US, EU, and Canadian regulatory filings with a working knowledge of and a willingness to learn other global regulatory requirements.
    • Ability to understand and explain detailed regulatory frameworks and requirements.
    • Must have strong planning and organizational skills with the ability to prioritize work and manage time effectively in both a team environment and as an individual contributor.
    • Must show attention to detail and have the ability to concurrently work with multiple deadlines while remaining results oriented. Must have excellent analytical, verbal and written communications skills.
    • Demonstrated experience with data analytics and configuring and using web-based solutions and other technology tools that enable and enhance compliance processes and controls is strongly preferred.
    • Excellent collaboration and interpersonal skills and the ability to influence across functions and geographies.
    • Motivated self-starter with strong follow through and excellent judgment.
    • Work in a global organization is a plus.
    • Occasional travel may be required.Preferred Qualifications
      • RAC certification preferred.A background check and screen for the illegal use of drugs is required.A-dec is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. In addition, A-dec will not discriminate against applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another. *VEVRAA Federal Contractor"
        A-dec is interested in qualified candidates authorized to work in the United States for US-based positions. We are unable to sponsor or take over sponsorship of employment visas.

Keywords: A-dec, Portland , Sr. Regulatory Specialist, Other , Newberg, Oregon

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