Principal Regulatory Affairs Specialist

2 weeks ago

Portage, United States Stryker Corporation Full time

**Why RA/QA at Stryker?**:
We are currently seeking a** Principal Regulatory Affairs Specialis**t for our Medical division to be based remotely anywhere within the US.

**Who we want**
- ** Strategic thinkers. **People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
- ** Goal-oriented orchestrators. **People who can effectively coordinate and focus the work of skilled employees toward an important goal, prioritizing to the right activities that lead to success.
- ** Business-oriented evaluators. **People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.

**What you will do**

As the **Principal Regulatory Affairs Specialist**, you will engage in our global footprint at the Stryker Medical Division driving Mergers and Acquisitions activities, engaging all our sites to a divisional Quality System, and leading/supporting projects and initiatives in our Divisional Quality Plan. You will lead the RAQA M&A activities partnering with the business development teams to evaluate targets. As an SME, your judgement and guidance will help drive diligence assessments to inform the business of deal driver decisions. As a member of our RAQA Systems team you’ll also be engaged in Divisional Projects and helping support the Process Ownership Platform as we enhance the overall capabilities of the Medical Division and provide guidance and leadership to the RAQAC team.

**Business Development & Integration**
- Drive the execution of the Mergers and Acquisitions (M&A) process for ensuring timely integration of pre-close and post-close activities.
- Operate as the Divisional Process Owner (DPO) of the M&A process.
- Lead/Support integration related activities as part of business development (BD).
- Through research and expertise, create in-depth analysis as part of evaluating business opportunities to help guide decision making.
- Develop strategies and improvements to the methods of executing the integration process.
- Ability to provide regulatory judgement for products and QMS’s and with BD targets and active integrations.

**Divisional Quality Plan & RAQAC PMO Office**
- Drive and execute projects as part of the Divisional Quality Plan
- Builds successful working relationships with internal and external personnel in various departments and sites across the globe.
- Drive results in support of the business, even in the face of demanding timelines. Steps up to take on additional responsibility where appropriate.
- Has the ability to influence without direct authority in a way that makes others want to be on their team.
- Exercises good judgment and can weigh benefits and risks to make solid decisions despite ambiguity.
- Ability to learn quickly and adapt to a changing environment.

**Divisional Quality System & Process Ownership Platform**
- Engage/Support the Process Ownership Platform which may include identification of new process owners, training process owners, and facilitating process owner forums to ensure an efficient and effective quality system across all division sites.
- Partner with other departments (e.g., R&D, RA, Operations, Operations Quality, Supplier Quality, Approvals) to develop and deploy the divisional quality system.
- Provide leadership and engagement with business partners across the Medical Division to foster collaboration across our global business and ensure effective and compliant quality system processes.

**What you need**
- Bachelors Degree required; preferably in Science, Engineering, or related
- Masters in Regulatory Science or RAC preferred
- Minimum 9 years of experience in Medical Device Regulatory Affairs
- Demonstrated knowledge and skills in areas such as regulatory pathways; risk-benefit analysis; communication and collaboration internally and externally; submission, registration, obtaining approval, documentation, compliance, post-marketing surveillance/vigilance; and distribution

$112,800.00 - $239,900.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

**About Stryker**:
**Our benefits**:

- 12 paid holidays annually
- Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
- Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits

**About Stryker**

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