Sr. Regulatory Specialist
Posted on: June 25, 2022
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
- 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
- Create, maintain and support Regulatory Team processes and
- 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
- 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
- Excellent collaboration and interpersonal skills and the
ability to influence across functions and geographies.
- Motivated self-starter with strong follow through and excellent
- 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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