Principal Reg Specialist
Influence Regulatory Strategy for Products That Reach Global Markets
The Opportunity
A global medical device manufacturer is looking for a Regulatory Affairs Specialist to join a well-established regulatory team supporting a diverse product portfolio.
This is a role for someone who wants to move beyond transactional regulatory work and become a valued contributor to product development and market strategy. You'll work closely with engineering, quality, operations, and commercial teams, helping navigate regulatory requirements that directly affect how products are developed, approved, and maintained throughout their lifecycle.
The company offers the scale and resources of an established organization, while still providing the visibility and access needed to make a meaningful contribution. Regulatory Affairs is viewed as a business partner, not a back-office function.
What You'll Be Doing
- Contribute to regulatory strategies that support product launches, changes, and market expansion.
- Partner with cross-functional teams throughout the product lifecycle.
- Support regulatory submissions and product registrations across global markets.
- Provide practical regulatory guidance that helps teams make informed decisions.
- Monitor regulatory developments and assess their impact on products and business objectives.
- Help maintain a compliant, efficient approach to bringing medical devices to market.
What You'll Bring
- Experience in Regulatory Affairs within the medical device sector or another regulated product environment.
- Exposure to regulatory submissions, registrations, or interactions with health authorities.
- Familiarity with international regulatory frameworks and product lifecycle activities.
- Experience collaborating with quality, engineering, manufacturing, or product development teams.
- Strong written communication skills and attention to detail.
- A pragmatic approach to problem-solving and balancing regulatory requirements with business needs.
What You'll Get
Suggested salary range: $110,000-$135,000 base salary, depending on experience, plus bonus potential.
You'll also benefit from:
- The opportunity to support products used by clinicians and healthcare providers around the world.
- A broad regulatory remit with exposure to multiple products, projects, and markets.
- High visibility across technical and operational teams.
- A collaborative environment where regulatory input is valued early in the decision-making process.
- Long-term career growth within a stable and growing medical device organization.
FAQs
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