Regulatory Affairs Specialist

We need to output HTML fragment with sections only if content present. No job title heading. Use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide which sections have content. From description: There's a description paragraph about role, then "Essential Job Functions" list, then "Requirements Qualifications" (actually heading "Requirements Qualifications" but we need separate sections: maybe "Responsibilities" and "Requirements". Also "Qualifications" separate? The posting lumps "Requirements Qualifications". We can split: Responsibilities (essential job functions), Requirements (Bachelor's degree, experience, etc.), Qualifications (maybe same as requirements? but we can treat "Qualifications" as the bullet list of competencies? Actually they have "Competencies" after qualifications. So we can have sections: About the role (description paragraph), Responsibilities (essential job functions list), Requirements (Bachelor's degree, experience, etc.), Qualifications (maybe the list of knowledge, certifications?), Skills (competencies list), Benefits/Pay/Schedule not present, so omit. We must not include filler like "commensurate with experience". Not present. We need to preserve all substantive information. So we need to include all bullet points from essential job functions, requirements, qualifications, competencies, physical requirements, mental requirements, other requirements, work environment? The instructions: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The EEO statement is boilerplate; we should remove it. Also "Safeguard Medical is proud to be an Equal Employment Opportunity..." that's EEO, remove. Also "Work Environment" maybe not boilerplate but it's substantive? It describes noise level. Could be considered substantive; but we might include under a section? There's no heading for Work Environment in allowed headings; we could incorporate into Responsibilities or maybe a separate section? Not allowed headings besides those listed. So we could put work environment details in a

under maybe Responsibilities or About the role? Better to keep under About the role? But it's not about role. Could add a

after sections? The instruction: Output ONLY the HTML fragment. It didn't forbid extra paragraphs not under headings. But they said use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use

• for any list of duties/requirements/benefits, and

  for prose. So we can have prose paragraphs outside sections? Probably better to wrap each section with heading and content. For items that don't fit those headings, we could still include as prose under appropriate heading or as a separate

  without heading? The instruction: "Use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It doesn't say we cannot have other headings, but we should follow that pattern. Likely they expect sections only from that list. So we need to map content to those sections. Thus: - About the role: introductory paragraph(s) describing role. - Responsibilities: essential job functions list. - Requirements: Bachelor's degree, experience, etc. (the "Requirements Qualifications" block). - Qualifications: maybe the list of knowledge (FDA, MDD, EU MDR, Pharma plus, ISO, RAC certification) etc. Actually that block is under "Competencies"? Wait after "Requirements Qualifications" there is a paragraph "Competencies Ability to perform at high levels..." That seems like skills/competencies. So we can treat that as Skills. Thus: - Skills: competencies list (ability to perform..., knowledge of..., strong verbal..., strong team-working..., etc.) We also have Physical Requirements, Mental Requirements, Other Requirements, Work Environment. Those are not in allowed headings; maybe we can incorporate them into Responsibilities or Requirements? But they are not duties/requirements/benefits. Could be considered part of Requirements? Possibly we could add a

  under Requirements for physical/mental/other requirements. But the instruction: Use

  • for any list of duties/requirements/benefits, and

    for prose. So we can put those as prose under Requirements. Thus: Section About the role: prose paragraph(s) from first paragraph. Section Responsibilities:

    • list of essential job functions. Section Requirements: include Bachelor's degree, experience, etc. plus physical/mental/other requirements and work environment as prose. Section Qualifications: maybe not needed if we merged into Skills? But we have a separate "Qualifications" heading allowed. Could put the list of knowledge (FDA, MDD, EU MDR, Pharma plus, ISO, RAC certification) as
      • . However that list is actually part of Competencies? Let's re-examine original text: "Requirements Qualifications Bachelor’s Degree required At least 3 years of increasing Regulatory Affairs (Medical device and/or Pharma) experience Solid working knowledge of relevant domestic and global regulations and guidance Exercise outstanding judgment in all areas of responsibility. History of successful interactions with global regulatory authorities Computer proficient to include web browser/internet search, MS Outlook, Word, Excel, and Power Point capabilities. Technical competence includes the ability to learn new software and systems. A combination of education and experience may be considered Competencies Ability to perform at high levels in a thriving environment, preferably in the medical device industry or combination products industry.Knowledge of FDA, MDD, EU MDRKnowledge of Pharma is a plus and ISO regulations/standards, including ISO 10993 (requirements for biocompatibility).RAC certification is a plus.Ability to focus and achieve scheduled milestones, including contingency planning.Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.Strong team-working and organizational skills with a drive to complete tasks in the face of obstacles and time constraints, and a willingness to collaborate wherever needed. Physical Requirements Performing the duties of this job regularly involves sitting, standing, walking, hearing/listening, repetitive hand movement, grasping and reaching. Vision requirements include the ability for close vision, to adjust focus, to color code. Mental Requirements This position requires the ability to maintain an appropriate work pace; to comprehend and follow instructions; to read, count and compute; to exercise logic and reasoning; to organize and prioritize; to problem solve; to make decisions; to analyze and interpret data; to multi-task/re-direct and experience numerous interruptions. Other Requirements Some travel, approximately 15% Work Environment The noise level in the work environment is usually quiet to moderate." Thus after "Requirements Qualifications" there is a run-on text that includes competencies, physical requirements, etc. So we need to parse. Thus we can have: - About the role: first paragraph(s) before "Essential Job Functions". Actually the description starts: "Description The Regulatory Affairs Specialist will be responsible for activities related to execution of established regulatory strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs. As an integral member of the Regulatory Affairs team, this position is versatile and executes various activities with both RA compliance and RA submission responsibilities. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory compliance and submission processes. This individual will provide a sense of urgency to cross-functional teams assisting with global programs and ensure effective communication with business partners worldwide." That's the About the role. - Responsibilities: list after "Essential Job Functions". We'll extract each bullet (sentences separated by periods). We'll need to make list items. - Requirements: Bachelor's degree required, at least 3 years experience, solid working knowledge..., exercise outstanding judgment..., history of successful interactions..., computer proficient..., technical competence..., combination of education and experience may be considered. - Qualifications: maybe we could treat the "Competencies" block as Skills, but we have Skills heading allowed. So we put competencies list under Skills. - Physical/Mental/Other/Work Environment: could be placed under Requirements as prose, or maybe under a separate section? Not allowed. We'll put them under Requirements as prose paragraphs. Thus final HTML:

        About the role

        ...

        Responsibilities

        • Review labeling, training, and promotional material
        • Support product and shipping release.
        • Maintenance of FDA’s GUDID database
        • Technical file update and reviews
        • Review of External Standards
        • Support business with government queries and registration documentation requirements.
        • Review Change Orders and assess regulatory impact of product changes on US and/or International regulatory strategy and submissions
        • Support post market regulatory compliance activities for US/International product approvals
        • Assist with the development and maintenance of regulatory affairs department procedures
        • Comply with applicable FDA and international regulatory laws/standards
        • Ensure relevant ISO and FDA Export requirements are met, as required
        • Performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
        • Compiles all materials to support submissions, license renewal and annual registrations.
        • Keeps abreast of regulatory procedures and changes.
        • Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
        • Customer Service Support
        • Proactively drive activities to meet and/or exceed company objectives.
        • Maintain regulatory files/database and chronologies in good order.
        • Manage interactions with distributors, consultants, and/or partners.
        • Perform other related duties and responsibilities as assigned.

        Requirements

        Bachelor’s Degree required

        At least 3 years of increasing Regulatory Affairs (Medical device and/or Pharma) experience

        Solid working knowledge of relevant domestic and global regulations and guidance

        Exercise outstanding judgment in all areas of responsibility.

        History of successful interactions with global regulatory authorities

        Computer proficient to include web browser/internet search, MS Outlook, Word, Excel, and Power Point capabilities.

        Technical competence includes the ability to learn new software and systems.

        A combination of education and experience may be considered

        Physical Requirements: Performing the duties of this job regularly involves sitting, standing, walking, hearing/listening, repetitive hand movement, grasping and reaching. Vision requirements include the ability for close vision, to adjust focus, to color code.

        Mental Requirements: This position requires the ability to maintain an appropriate work pace; to comprehend and follow instructions; to read, count and compute; to exercise logic and reasoning; to organize and prioritize; to problem solve; to make decisions; to analyze and interpret data; to multi-task/re-direct and experience numerous interruptions.

        Other Requirements: Some travel, approximately 15%

        Work Environment: The noise level in the work environment is usually quiet to moderate.

        Skills

        • Ability to perform at high levels in a thriving environment, preferably in the medical device industry or combination products industry.
        • Knowledge of FDA, MDD, EU MDR
        • Knowledge of Pharma is a plus and ISO regulations/standards, including ISO 10993 (requirements for biocompatibility).
        • RAC certification is a plus.
        • Ability to focus and achieve scheduled milestones, including contingency planning.
        • Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.
        • Strong team-working and organizational skills with a drive to complete tasks in the face of obstacles and time constraints, and a willingness to collaborate wherever needed.
        We must not include Benefits, Pay, Schedule