Regulatory Affairs Manager

DePuy Synthes is recruiting for a Regulatory Affairs Manager, located in West Chester, Pennsylvania, United States or in Zuchwil, Switzerland.

The Regulatory Affairs Manager is responsible for manging regulatory activities & personnel to support new, modified and currently marketed medical devices within the Trauma, Extremities, CMF, and Animal health (TECA) franchise.

**Key Responsibilities**:

- Act as a strategic partner with colleagues in R&D, Quality, Clinial Affairs, Marketing, Supply Chain, and other functions to develop and implement global regulatory strategies for new and existing products to assure on-time regulatory approval/clearance and post-marketing activities.
- Demonstrate a deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products.
- Develop and submit US and EU regulatory filings such as pre-submissions, 510(k)s, and EU MDR TDs. Partner with regional leaders on regulatory strategy and submissions to successfully obtain marketing approvals for all other intended markets.
- Partner with Regulatory Affairs colleagues to monitor, assess, and communicate the impact of current and emerging regulations on the company's portfolio of products, define the future vision, and drive innovative thinking.
- Provide key input for product claims and evidence support, and review & approve labeling and Advertising & Promotional materials in accordance with local regulations.
- Review product design, labeling, and manufacturing changes to existing products to assess the impact to safety and efficacy.
- Collaborate with Legal, Medical, and Quality partners regarding product safety and quality issues. Contribute to risk management plans and product investigations during safety signal detection.
- Manage, oversee, and balance resource allocation across assigned projects and personnel.
- Lead, inspire, and mentor RA staff members, directly or indirectly.
- Influence and collaborate to bring about process and technical improvements within the organization.
- Diligently participate in training to policies & procedures and in compliance-related activities as required.
- Ensure organizational compliance with all applicable regulations and J&J policies.
- Perform other duties as assigned.

**Qualifications**
Education**:

- A minimum of Bachelor’s Degree is required.
- A degree in Science, Engineering, or Technical field is preferred.

**Required Skills & Experience**:

- At least 7 years of direct regulatory experience
- Experience with US and European medical device regulatory processes, including preparing and submitting regulatory filings
- Proven track record of developing and implementing global regulatory strategies that align with business results
- Prior experience in directly managing personnel

**Preferred Skills & Experience**:

- Previous experience with: orthopedic devices, patient specific (i.e. custom or customized) devices, and/or digital and software related products
- Experience working closely with and negotiating with Health Authorities

**Other**:

- This position will be located in West Chester, PA or Zuchwil, CH and may require up to 10% domestic/international travel.
- Current J&J flex policy includes the potential for working remotely 2-3 days per week and being in the office 2-3 days per week.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

**Primary Location**
United States-Pennsylvania-West Chester-1301 Goshen Parkway
**Other Locations**
Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil
**Organization**
Medical Device Business Services, Inc (6029)
**Job Function**
Regulatory Affairs
**Requisition ID**
2206030497W