Manager, Regulatory Affairs

vor 2 Wochen

Oberdorf, Schweiz Johnson & Johnson Vollzeit

**Job Function**:
Regulatory Affairs Group
**Job Sub Function**:
Regulatory Affairs
**Job Category**:
People Leader
**All Job Posting Locations**:
Oberdorf, Basel-Country, Switzerland, Zuchwil, Switzerland

United States - Requisition Number**:R-021721**

Switzerland - Requisition Number**:R-023294**

**Purpose**: The Manager, Regulatory Affairs will lead, direct, and coordinate activities concerned with the submission and approval of new and/or modified products to government regulatory agencies. They will also lead, direct, and coordinate activities to ensure the regulatory compliance, maintain market access and regulatory agency commitments.

**You will be responsible for**:

- Lead, direct, and coordinate activities concerned with the submission and approval of products to government regulatory agencies.
- Provide mentorship to project team members regarding regulatory compliance issues.
- Lead all aspects of the preparation and maintenance of regulatory submissions and files.
- Establish accountability for the preparation of vital outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Ensure adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products.
- Collaborate with management personnel to establish and prepare appropriate regulatory filings for product approvals.
- Ensure organizational compliance with all applicable regulations and J&J policies.
- Assign projects or activities, provide day-to-day instructions, and suggested training activities to direct reports (if any).

**Qualifications / Requirements**:

- Minimum of Bachelor’s Degree **required**, Advanced Degree _stongly preferred_. Study in a scientific, engineering, business, or legal discipline desired.
- ** At least 8+ years** of relevant regulatory experience (6+ years with Master’s, 5+ years with PhD); Medical Device regulatory experience _strongly preferred_.
- Experience with US and European medical device regulatory processes **required**.
- Experience in preparing and submitting US regulatory files (510(k)s, PMAs) as well as European Technical Files and Design Dossiers
- Demonstrated track record of developing and implementing global regulatory strategies that align with business results
- FTE Leadership experience is _preferred_.
- Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
- Ability to effectively present information to top management and peers.

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