Goal templates — Health Technology and Medical Devices Medical Device Regulatory Affairs Manager
Health Technology and Medical Devices · General · M3 — Senior Manager
These are canon-derived frames, not advice: every line is either verbatim JobFrame canon text or a fixed template wrapping it. ⟨target⟩ / ⟨baseline⟩ / ⟨date⟩ are placeholders for the manager to fill in. Nothing here is generated by AI — rows are omitted, never invented, when the canon lacks the underlying field.
MBO areas
Key result areas from this level's responsibilities, each with a standard grounded in the canon leveling rubric where one exists.
| Area | Standard | Target | Due |
|---|---|---|---|
| Develop regulatory plans for new devices/diagnostics | Consistent with this level's decision rights: "Owns goals, budget input, and people decisions across teams" | ⟨target⟩ | ⟨date⟩ |
| Compile and submit regulatory applications | Consistent with this level's decision rights: "Owns goals, budget input, and people decisions across teams" | ⟨target⟩ | ⟨date⟩ |
| Liaise with regulatory agencies | Consistent with this level's decision rights: "Owns goals, budget input, and people decisions across teams" | ⟨target⟩ | ⟨date⟩ |
| Monitor and interpret changes in global medical device regulations | Consistent with this level's decision rights: "Owns goals, budget input, and people decisions across teams" | ⟨target⟩ | ⟨date⟩ |
| Oversee the company’s quality management system | Consistent with this level's decision rights: "Owns goals, budget input, and people decisions across teams" | ⟨target⟩ | ⟨date⟩ |
| Analyze customer needs and industry trends | Consistent with this level's decision rights: "Owns goals, budget input, and people decisions across teams" | ⟨target⟩ | ⟨date⟩ |
| Define the product vision and value proposition | Consistent with this level's decision rights: "Owns goals, budget input, and people decisions across teams" | ⟨target⟩ | ⟨date⟩ |
| Collaborate with engineering on requirements and specifications | Consistent with this level's decision rights: "Owns goals, budget input, and people decisions across teams" | ⟨target⟩ | ⟨date⟩ |
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1. Area: Develop regulatory plans for new devices/diagnostics [source: responsibility (component)] Standard: Consistent with this level's decision rights: "Owns goals, budget input, and people decisions across teams" Target: ⟨target⟩ Due: ⟨date⟩ 2. Area: Compile and submit regulatory applications [source: responsibility (component)] Standard: Consistent with this level's decision rights: "Owns goals, budget input, and people decisions across teams" Target: ⟨target⟩ Due: ⟨date⟩ 3. Area: Liaise with regulatory agencies [source: responsibility (component)] Standard: Consistent with this level's decision rights: "Owns goals, budget input, and people decisions across teams" Target: ⟨target⟩ Due: ⟨date⟩ 4. Area: Monitor and interpret changes in global medical device regulations [source: responsibility (component)] Standard: Consistent with this level's decision rights: "Owns goals, budget input, and people decisions across teams" Target: ⟨target⟩ Due: ⟨date⟩ 5. Area: Oversee the company’s quality management system [source: responsibility (component)] Standard: Consistent with this level's decision rights: "Owns goals, budget input, and people decisions across teams" Target: ⟨target⟩ Due: ⟨date⟩ 6. Area: Analyze customer needs and industry trends [source: responsibility (component)] Standard: Consistent with this level's decision rights: "Owns goals, budget input, and people decisions across teams" Target: ⟨target⟩ Due: ⟨date⟩ 7. Area: Define the product vision and value proposition [source: responsibility (component)] Standard: Consistent with this level's decision rights: "Owns goals, budget input, and people decisions across teams" Target: ⟨target⟩ Due: ⟨date⟩ 8. Area: Collaborate with engineering on requirements and specifications [source: responsibility (component)] Standard: Consistent with this level's decision rights: "Owns goals, budget input, and people decisions across teams" Target: ⟨target⟩ Due: ⟨date⟩
Scorecard
Only perspectives with real canon backing are shown — no Financial or Customer perspective, since nothing in the canon grounds business-financial or customer measures for a role alone.
Learning & growth
- Proficiency: "Critical Thinking"→ ⟨target⟩ by ⟨date⟩
- Proficiency: "Reading Comprehension"→ ⟨target⟩ by ⟨date⟩
- Proficiency: "Active Listening"→ ⟨target⟩ by ⟨date⟩
- Proficiency: "Complex Problem Solving"→ ⟨target⟩ by ⟨date⟩
- Proficiency: "Speaking"→ ⟨target⟩ by ⟨date⟩
- Proficiency: "Programming"→ ⟨target⟩ by ⟨date⟩
Role calibration
- Meets the scope bar: "Multiple teams or a sub-function"→ ⟨target⟩ by ⟨date⟩
- Meets the autonomy bar: "Sets goals within functional strategy"→ ⟨target⟩ by ⟨date⟩
- Meets the complexity bar: "Multi-team execution and resourcing trade-offs"→ ⟨target⟩ by ⟨date⟩
- Meets the impact bar: "Sub-function outcomes"→ ⟨target⟩ by ⟨date⟩
- Meets the decision rights bar: "Owns goals, budget input, and people decisions across teams"→ ⟨target⟩ by ⟨date⟩
- Meets the leadership bar: "Manages managers and/or several teams"→ ⟨target⟩ by ⟨date⟩
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Learning & growth - Proficiency: "Critical Thinking" → ⟨target⟩ by ⟨date⟩ [source: O*NET skill (MF-118 KSA)] - Proficiency: "Reading Comprehension" → ⟨target⟩ by ⟨date⟩ [source: O*NET skill (MF-118 KSA)] - Proficiency: "Active Listening" → ⟨target⟩ by ⟨date⟩ [source: O*NET skill (MF-118 KSA)] - Proficiency: "Complex Problem Solving" → ⟨target⟩ by ⟨date⟩ [source: O*NET skill (MF-118 KSA)] - Proficiency: "Speaking" → ⟨target⟩ by ⟨date⟩ [source: O*NET skill (MF-118 KSA)] - Proficiency: "Programming" → ⟨target⟩ by ⟨date⟩ [source: O*NET skill (MF-118 KSA)] Role calibration - Meets the scope bar: "Multiple teams or a sub-function" → ⟨target⟩ by ⟨date⟩ [source: level dimension (Scope)] - Meets the autonomy bar: "Sets goals within functional strategy" → ⟨target⟩ by ⟨date⟩ [source: level dimension (Autonomy)] - Meets the complexity bar: "Multi-team execution and resourcing trade-offs" → ⟨target⟩ by ⟨date⟩ [source: level dimension (Complexity)] - Meets the impact bar: "Sub-function outcomes" → ⟨target⟩ by ⟨date⟩ [source: level dimension (Impact)] - Meets the decision rights bar: "Owns goals, budget input, and people decisions across teams" → ⟨target⟩ by ⟨date⟩ [source: level dimension (Decision rights)] - Meets the leadership bar: "Manages managers and/or several teams" → ⟨target⟩ by ⟨date⟩ [source: level dimension (Leadership)]